Merge Healthcare, Inc.: 93 FDA recall reports
Every medical device recall the FDA has published for Merge Healthcare, Inc.. The fault, and how the agency graded it.
93Reports
0Class I
6Ongoing
2025-09-10Most 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.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Descript
Z-2518-2025 · Class II · reported 2025-09-10 · Ongoing
- Why it was recalled
- Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
- Product
- Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
- Where it went
- US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisconsin.
- How much
- 84
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an int
Z-1398-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Product
- VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
- Where it went
- US
- How much
- 2
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 1
Z-1399-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Product
- VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
- Where it went
- US
- How much
- 11
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2,
Z-1402-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Product
- Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
- Where it went
- US
- How much
- 253
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an
Z-1401-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Product
- VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
- Where it went
- US
- How much
- 37
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.
Z-1400-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Product
- VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
- Where it went
- US
- How much
- 66
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Z-2387-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface.
- Product
- Merge Hemo, Software packages 10.2, 10.3, and 10.4
- Where it went
- US distribution
- How much
- 326 units
Merge LIS
Z-0289-2021 · Class II · reported 2020-11-04 · Terminated
- Why it was recalled
- A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
- Product
- Merge LIS
- Where it went
- Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
- How much
- 47 units
Merge PACS
Z-2944-2020 · Class II · reported 2020-09-16 · Terminated
- Why it was recalled
- Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
- Product
- Merge PACS
- Where it went
- Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.
- How much
- 125 total units
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Softw
Z-2403-2020 · Class II · reported 2020-07-01 · Terminated
- Why it was recalled
- An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
- Product
- Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
- Where it went
- US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.
- How much
- 62 units
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Z-2063-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
- Product
- Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
- Where it went
- Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
- How much
- 73 devices
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Z-2062-2019 · Class II · reported 2019-07-31 · Terminated
- Why it was recalled
- Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
- Product
- Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
- Where it went
- Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
- How much
- 179 devices
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System P
Z-0939-2019 · Class II · reported 2019-03-06 · Terminated
- Why it was recalled
- Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).
- Product
- The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
- Where it went
- Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West , Virginia, Wisconsin. International distribution to Algeria, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Israel, Netherlands, Puerto Rico, United Kingdom.
- How much
- 1,252 Units
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge H
Z-2566-2018 · Class II · reported 2018-08-08 · Terminated
- Why it was recalled
- The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Product
- Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
- Where it went
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- How much
- 11 sites have potentially affected software
Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Numbe
Z-0350-2018 · Class II · reported 2018-01-24 · Terminated
- Why it was recalled
- Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
- Product
- Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
- Where it went
- Nationwide.
- How much
- 1,150 power strips
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge H
Z-3105-2017 · Class II · reported 2017-09-13 · Terminated
- Why it was recalled
- The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Product
- Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
- Where it went
- Nationwide Distribution
- How much
- 98 sites have the potentially affected software
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archiv
Z-2754-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
- Product
- Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
- Where it went
- FL, IL, CO, MI, CA, NY, ND, OH, CT
- How much
- 18 units
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo
Z-2707-2017 · Class II · reported 2017-07-19 · Terminated
- Why it was recalled
- If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.
- Product
- The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
- Where it went
- Distribution US nationwide.
- How much
- 555 PDM's
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics
Z-2641-2017 · Class II · reported 2017-07-05 · Terminated
- Why it was recalled
- Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Product
- Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
- Where it went
- Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
- How much
- 2 sensors
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemo
Z-2640-2017 · Class II · reported 2017-07-05 · Terminated
- Why it was recalled
- Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Product
- SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
- Where it went
- Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
- How much
- 219 cables
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: H
Z-2642-2017 · Class II · reported 2017-07-05 · Terminated
- Why it was recalled
- Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Product
- MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
- Where it went
- Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
- How much
- 4 sensors
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product
Z-2643-2017 · Class II · reported 2017-07-05 · Terminated
- Why it was recalled
- Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Product
- MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
- Where it went
- Distribution was nationwide. There was also government and military distribution. There was no foreign distribution.
- How much
- 65 sensors
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system
Z-2628-2017 · Class II · reported 2017-07-05 · Terminated
- Why it was recalled
- There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
- Product
- Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
- Where it went
- Nationwide Distribution to facilities and distributors. Distribution was made to the Virgin Islands. Foreign distribution was also made. There was no military/government distribution.
- How much
- 638 sites have the potentially affected versions
Merge OrthoPACS software.
Z-2620-2017 · Class II · reported 2017-06-28 · Terminated
- Why it was recalled
- A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
- Product
- Merge OrthoPACS software.
- Where it went
- Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
- How much
- 98 sites potentially have the affected versions
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Z-2601-2017 · Class II · reported 2017-06-28 · Terminated
- Why it was recalled
- Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
- Product
- Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Where it went
- USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
- How much
- 160 sites potentially have the affected versions
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft c
Z-2591-2017 · Class II · reported 2017-06-21 · Terminated
- Why it was recalled
- When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
- Product
- Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
- Where it went
- Nationwide Distribution
- How much
- 47 sites have the potentially affected versions
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Z-2590-2017 · Class II · reported 2017-06-21 · Terminated
- Why it was recalled
- Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Where it went
- USA (nationwide) Distribution .There was no foreign/government/military distribution.
- How much
- 47 sites potentially have the affected versions
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used
Z-2123-2017 · Class II · reported 2017-05-31 · Terminated
- Why it was recalled
- Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
- Where it went
- Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
- How much
- 30 sites have the potentially affected software versions
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optio
Z-1923-2017 · Class II · reported 2017-05-10 · Terminated
- Why it was recalled
- The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.
- Product
- Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
- Where it went
- US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
- How much
- 23 sensors (PhaseIn Units)
Merge Eye Station and Merge Eye Care PACS.
Z-1828-2017 · Class II · reported 2017-04-26 · Terminated
- Why it was recalled
- During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.
- Product
- Merge Eye Station and Merge Eye Care PACS.
- Where it went
- Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.
- How much
- 1,627 sites potentially have the affected versions
Showing the 30 most recent of 93. The rest are searchable at the FDA enforcement report database.
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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