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Spacelabs Healthcare Inc
Spacelabs Healthcare Inc: 30 FDA recall reports
Every medical device recall the FDA has published for Spacelabs Healthcare Inc. The fault, and how the agency graded it.
30Reports
0Class I
9Ongoing
2026-05-13Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 9149
Z-2052-2026 · Class II · reported 2026-05-13 · Ongoing
- Why it was recalled
- Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
- Product
- Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
- Where it went
- Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA.
- How much
- 57
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Z-1793-2026 · Class II · reported 2026-04-15 · Ongoing
- Why it was recalled
- Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
- Product
- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
- Where it went
- Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.
- How much
- 1790
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number:
Z-0169-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Product
- Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
- Where it went
- Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.
- How much
- 16898
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number:
Z-0168-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Product
- Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
- Where it went
- Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.
- How much
- 820
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number:
Z-0167-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- Product
- Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
- Where it went
- Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.
- How much
- 8179
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with pati
Z-0809-2025 · Class II · reported 2025-01-15 · Ongoing
- Why it was recalled
- Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
- Product
- Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
- Where it went
- US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR. OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech Republic
- How much
- 2265
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data
Z-0810-2025 · Class II · reported 2025-01-15 · Ongoing
- Why it was recalled
- Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
- Product
- Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
- Where it went
- US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.
- How much
- 434
Ultraview SL (UVSL) Command Module, Model 91496
Z-1503-2023 · Class II · reported 2023-05-10 · Ongoing
- Why it was recalled
- Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.
- Product
- Ultraview SL (UVSL) Command Module, Model 91496
- Where it went
- US Nationwide distribution in the states of SD, KY, MO, WA, OH, NC, CA, OR, TX, GA, IL, OK, SC, PA, AL, KS, FL, ID, MI, MN, IA, NJ, MD, VA, AR, CT, NE, LA, AK, MS, ME, WV, NY, AZ, TN, WY, IN, MA, MT, CO, DE, ND, WI, NV, RI, NH, UT.
- How much
- 1,088
Xhibit Telemetry Receiver, Model: 96280
Z-1513-2022 · Class II · reported 2022-08-17 · Ongoing
- Why it was recalled
- Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
- Product
- Xhibit Telemetry Receiver, Model: 96280
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.
- How much
- 529
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring
Z-2261-2020 · Class II · reported 2020-06-10 · Terminated
- Why it was recalled
- The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
- Product
- Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.
- How much
- 2197 units
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Z-2035-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
- Product
- Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
- Where it went
- Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.
- How much
- 295 customer sites have the affected software versions
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monit
Z-0532-2018 · Class II · reported 2018-02-14 · Terminated
- Why it was recalled
- Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
- Product
- Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
- Where it went
- US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
- How much
- 12 systems
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adu
Z-0332-2017 · Class II · reported 2016-11-09 · Terminated
- Why it was recalled
- The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
- Product
- Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
- Where it went
- Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
- How much
- 348 units (292 units in the US and 56 units outside the US)
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be c
Z-2886-2016 · Class II · reported 2016-10-05 · Terminated
- Why it was recalled
- The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
- Product
- Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
- How much
- 316 XTR units total (248 units in the US and 68 units outside US)
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) mu
Z-2885-2016 · Class II · reported 2016-10-05 · Terminated
- Why it was recalled
- The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
- Product
- Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
- How much
- 798 units total (488 units in the US and 310 units outside US)
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2
Z-2343-2016 · Class II · reported 2016-08-10 · Terminated
- Why it was recalled
- The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.
- Product
- 91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.
- Where it went
- Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM; CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC; ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
- How much
- 3801 modules and 116 PCBAs & valves distributed in the US; 1297 modules and 366 PCBAs & valves distributed outside the US
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiolog
Z-1502-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored.
- Product
- The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
- Where it went
- distributed in AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY and in the following countries: AUSTRALIA, CANADA, CHINA, FRANCE, NETHERLANDS, PHILIPPINES, ROMANIA, and UNITED KINGDOM.
- How much
- 217 units of XTRs and 531 units of PCBAs (164 XTRs and 425 PCBAs in US and 53 XTRs and 106 PCBAs outside the US)
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring
Z-1092-2016 · Class II · reported 2016-03-16 · Terminated
- Why it was recalled
- The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calculation to be in error.
- Product
- Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
- Where it went
- distributed in AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WY and Guam and in the following countries AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, EL SALVADOR, FRANCE, GERMANY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ITALY, KUWAIT, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, SAUDI ARABIA, SINGAPORE, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, and UNITED KINGDOM.
- How much
- total 1075 units (614 units in the US and 461 outside the US)
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00
Z-0172-2016 · Class II · reported 2015-11-04 · Terminated
- Why it was recalled
- When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.
- Product
- Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
- Where it went
- Worldwide Distribution - US Distribution in the states of Nebraska, South Carolina, and Washington and in the following countries of AUSTRALIA, BELGIUM, BOLIVIA, CANADA, CHILE, DENMARK, GERMANY, GUATEMALA, HONG KONG, ITALY, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, QATAR, SINGAPORE, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- How much
- 275 devices (20 in US and 255 international) and 113 PCBAs (international only)
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors
Z-1608-2015 · Class II · reported 2015-05-20 · Terminated
- Why it was recalled
- The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
- Product
- Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.
- Where it went
- distributed in North Carolina, Texas, and Wyoming
- How much
- 5 units distributed in the US
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi
Z-1577-2015 · Class II · reported 2015-05-13 · Terminated
- Why it was recalled
- Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.
- Product
- Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
- Where it went
- Worldwide Distribution:US (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, ID, IL, LA, ME, MI, MN, MO, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WY, and Puerto Rico and countries of: Argentina, Australia, Bangladesh, Canada, Chile, France, Great Britain, India, Kuwait, Panama, Poland, Qatar, Saudi Arabia, and Turkey. .
- How much
- 1973 units total (1345 modules in the US and 604modules international and 3 PCBAs in US and 21 PCBAs international)
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spa
Z-1542-2015 · Class II · reported 2015-05-06 · Terminated
- Why it was recalled
- Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
- Product
- Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
- Where it went
- Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.
- How much
- 1999 units total (1932 in the US and 67 international)
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor
Z-1144-2015 · Class II · reported 2015-03-04 · Terminated
- Why it was recalled
- Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.
- Product
- Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
- Where it went
- Worldwide Distribution.
- How much
- total 1578 units (702 units in the US and 876 outside US)
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91
Z-1145-2015 · Class II · reported 2015-03-04 · Terminated
- Why it was recalled
- Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.
- Product
- Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
- Where it went
- Worldwide Distribution.
- How much
- total 2955 units (2117 units in US and 838 units outside US)
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The
Z-2707-2014 · Class II · reported 2014-10-01 · Terminated
- Why it was recalled
- The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011).
- Product
- Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
- Where it went
- Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
- How much
- 82 units distributed in US and 140 units distributed outside US
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a ho
Z-2586-2014 · Class II · reported 2014-09-10 · Terminated
- Why it was recalled
- The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.
- Product
- ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
- Where it went
- US Distribution to TX.
- How much
- 8 units
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of mo
Z-2077-2014 · Class II · reported 2014-07-23 · Terminated
- Why it was recalled
- With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
- Product
- Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.
- Where it went
- Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
- How much
- 8 units total (3 units in US)
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that
Z-1852-2014 · Class II · reported 2014-07-02 · Terminated
- Why it was recalled
- Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
- Product
- Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
- Where it went
- Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
- How much
- 3383 in the USA; 1459 outside the USA
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Z-1824-2014 · Class II · reported 2014-06-25 · Terminated
- Why it was recalled
- Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
- Product
- Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
- Where it went
- Worldwide Distribution-USA (nationwide) including the states of AZ, IN, LA, GA, SC, FL, and NY, and 18 customers outside the US.
- How much
- 46 units distributed within the US; 108 units distributed outside the US.
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-para
Z-1705-2014 · Class II · reported 2014-06-11 · Terminated
- Why it was recalled
- A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
- Product
- Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
- Where it went
- US Distribution to GA.
- How much
- 64 devices
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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