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Trumpf Medical Systems, Inc.
Trumpf Medical Systems, Inc.: 30 FDA recall reports
Every medical device recall the FDA has published for Trumpf Medical Systems, Inc.. The fault, and how the agency graded it.
30Reports
0Class I
0Ongoing
2018-03-07Most 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.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical i
Z-0824-2018 · Class II · reported 2018-03-07 · Terminated
- Why it was recalled
- The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
- Product
- Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.
- Where it went
- Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA. and to the countries of : Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.
- How much
- 212 devices
OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model #
Z-0391-2017 · Class II · reported 2016-11-16 · Terminated
- Why it was recalled
- Trumpf has identified six incidents of pinched cables.
- Product
- OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AZ and SC and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Iceland, Italy, Norway, Qatar, Slovenia, Spain, Sweden, Switzerland
- How much
- 4 (US) & 229 (Foreign)
Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Nu
Z-0043-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- Product
- Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
- Where it went
- Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
- How much
- 84 units
Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822
Z-0040-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- Product
- Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system
- Where it went
- Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
- How much
- 84 units
Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878
Z-0042-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- Product
- Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
- Where it went
- Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
- How much
- 84 units
Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from
Z-0041-2017 · Class II · reported 2016-10-12 · Terminated
- Why it was recalled
- Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
- Product
- Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.
- Where it went
- Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland
- How much
- 84 units
Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Sa
Z-0759-2016 · Class II · reported 2016-02-17 · Terminated
- Why it was recalled
- Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
- Product
- Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
- Where it went
- Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
- How much
- 1284 affected units
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Z-0563-2016 · Class II · reported 2016-01-06 · Completed
- Why it was recalled
- The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
- Product
- Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
- Where it went
- USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
- How much
- 20,713
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surg
Z-2355-2015 · Class II · reported 2015-08-19 · Terminated
- Why it was recalled
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Where it went
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
- How much
- 9,287 units total
Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgi
Z-2354-2015 · Class II · reported 2015-08-19 · Terminated
- Why it was recalled
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Where it went
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
- How much
- 9,287 units total
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights
Z-2353-2015 · Class II · reported 2015-08-19 · Terminated
- Why it was recalled
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Where it went
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
- How much
- 9,287 units (total)
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lig
Z-2357-2015 · Class II · reported 2015-08-19 · Terminated
- Why it was recalled
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Where it went
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
- How much
- 9,287 units total
Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lig
Z-2356-2015 · Class II · reported 2015-08-19 · Terminated
- Why it was recalled
- Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Where it went
- Worldwide Distribution-US (nationwide) including Puerto Rico, and the countries of Angola, Antilles, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Belgium, Bulgaria, Bahrain, Brasilia, Belarus, Canada, Switzerland, Chile, China, Columbia, Cyprus, Czech Republic, Germany, Denmark, Algerian, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgian Republic, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Kazakhstan, Lebanon, Liechtenstein, Lithuania, Luxembourg, Latvia, Libya, Morocco, Macedonia, Myanmar/Burma, Malta, Mauritius, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Pakistan, Poland, Palestine, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sudan, Sweden, Singapore, Slovenia, Slovakia, San Marino, Syria, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, United Arabian Emirates, Uruguay, Venezuela, British Virgin Islands, Vietnam, Kosovo, Serbia and South Africa.*
- How much
- 9,287 units total
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning d
Z-0921-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positionin
Z-0925-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient posi
Z-0919-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning durin
Z-0926-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during su
Z-0927-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioni
Z-0928-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning
Z-0929-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning
Z-0918-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 137 units
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning dur
Z-0923-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positio
Z-0922-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning
Z-0920-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning d
Z-0924-2015 · Class II · reported 2015-01-14 · Terminated
- Why it was recalled
- Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
- Product
- (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS, NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
- How much
- 3303 total all devices
TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual
Z-0141-2015 · Class II · reported 2014-11-05 · Terminated
- Why it was recalled
- Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.
- Product
- TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
- Where it went
- Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.
- How much
- 184 units
Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient
Z-0484-2014 · Class II · reported 2013-12-18 · Terminated
- Why it was recalled
- Possible fatigue failure of the plastic joint may occur after an average use of seven years.
- Product
- Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
- Where it went
- US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
- How much
- 287
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU
Z-0342-2014 · Class II · reported 2013-11-27 · Terminated
- Why it was recalled
- The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
- Product
- TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
- Where it went
- US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
- How much
- 15 components
Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally i
Z-0077-2013 · Class II · reported 2012-10-24 · Terminated
- Why it was recalled
- Incidents regarding fractures of the front joint of the spring arm have been reported.
- Product
- Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
- Where it went
- Nationwide Distribution-USA (nationwide) including the states of AR, CA, CO, CT, FL, GA, IL, KS, MA, MI, MO, NC, NJ, NY, OH, SC, TX, UT, VT and WI.
- How much
- 275 units
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG
Z-2311-2012 · Class II · reported 2012-09-12 · Terminated
- Why it was recalled
- Cracks can arise on the welded seam on the rear joint.
- Product
- Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
- Where it went
- Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada
- How much
- 402 units
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.
← All device recalls