Merge Healthcare recalls
Merge Healthcare appears in 96 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 96 |
|---|---|
| Published | 2014-10-22 to 2026-09-02 |
| By agency | FDA Device (96) |
| By classification | Class II (96) |
| By status | terminated (87), ongoing (9) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare
Reason: Software issue may cause measurements to be displayed inaccurately. - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare
Reason: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare
Reason: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare
Reason: 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 ( Pressur… - 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
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Reason: 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… - 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
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Reason: 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… - 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
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Reason: 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… - VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Reason: 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… - VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8
FDA Device · Class II · 2025-03-26 · Merge Healthcare
Reason: 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… - Merge Hemo, Software packages 10.2, 10.3, and 10.4
FDA Device · Class II · 2021-09-08 · Merge Healthcare
Reason: 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. - Merge LIS
FDA Device · Class II · 2020-11-04 · Merge Healthcare
Reason: 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. - Merge PACS
FDA Device · Class II · 2020-09-16 · Merge Healthcare
Reason: Measurements done on the Merge PACS generated MPR s may have incorrect measurements. - Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage:…
FDA Device · Class II · 2020-07-01 · Merge Healthcare
Reason: 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. - Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare
Reason: 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… - Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare
Reason: 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… - The WinStation Retinal Imager, also known as Merge Eye Station
FDA Device · Class II · 2019-03-06 · Merge Healthcare
Reason: 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,… - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2018-08-08 · Merge Healthcare
Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. - Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two compon…
FDA Device · Class II · 2018-01-24 · Merge Healthcare
Reason: 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. - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2017-09-13 · Merge Healthcare
Reason: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. - Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration o…
FDA Device · Class II · 2017-07-26 · Merge Healthcare
Reason: 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… - The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software
FDA Device · Class II · 2017-07-19 · Merge Healthcare
Reason: 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… - Merge LIS software
FDA Device · Class II · 2017-07-05 · Merge Healthcare
Reason: There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified. - Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records ph…
FDA Device · Class II · 2017-07-05 · Merge Healthcare
Reason: 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. - SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and…
FDA Device · Class II · 2017-07-05 · Merge Healthcare
Reason: 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. - MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage:…
FDA Device · Class II · 2017-07-05 · Merge Healthcare
Reason: 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. - MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics moni…
FDA Device · Class II · 2017-07-05 · Merge Healthcare
Reason: 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. - Merge OrthoPACS software
FDA Device · Class II · 2017-06-28 · Merge Healthcare
Reason: 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. - Merge OrthoPACS software
FDA Device · Class II · 2017-06-28 · Merge Healthcare
Reason: 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. - Merge PACS software
FDA Device · Class II · 2017-06-21 · Merge Healthcare
Reason: 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. - Merge PACS software
FDA Device · Class II · 2017-06-21 · Merge Healthcare
Reason: 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. - Merge Cardio software
FDA Device · Class II · 2017-05-31 · Merge Healthcare
Reason: 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. - Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001
FDA Device · Class II · 2017-05-10 · Merge Healthcare
Reason: 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 measure… - Merge Eye Station and Merge Eye Care PACS
FDA Device · Class II · 2017-04-26 · Merge Healthcare
Reason: 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. - Merge Hemo software
FDA Device · Class II · 2017-04-19 · Merge Healthcare
Reason: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. - iConnect Enterprise Archive (ICEA) software
FDA Device · Class II · 2017-04-19 · Merge Healthcare
Reason: An error message can occur resulting in the prior studies being unavailable for viewing. - iConnect Enterprise Archive software
FDA Device · Class II · 2017-04-05 · Merge Healthcare
Reason: The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease. - Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU)
FDA Device · Class II · 2017-04-05 · Merge Healthcare
Reason: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. - iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and co…
FDA Device · Class II · 2017-04-05 · Merge Healthcare
Reason: The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease. - Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare
Reason: A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. - Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare
Reason: For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, la… - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare
Reason: Cardio study list does not show STAT studies without refreshing. - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare
Reason: Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation. - Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare
FDA Device · Class II · 2017-03-29 · Merge Healthcare
Reason: System locks up which may result in potential patient injury or delay in diagnosis or treatment. - Merge Hemo software
FDA Device · Class II · 2017-03-22 · Merge Healthcare
Reason: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. - iConnect Enterprise Archive when used with RadSuite
FDA Device · Class II · 2017-03-22 · Merge Healthcare
Reason: The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment. - DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Device · Class II · 2017-03-15 · Merge Healthcare
Reason: Reports were missing demographic header information when they were faxed to referring physicians. - Merge Cardio software
FDA Device · Class II · 2017-03-15 · Merge Healthcare
Reason: When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. - Merge PACS software
FDA Device · Class II · 2017-03-15 · Merge Healthcare
Reason: 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. - DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information managemen…
FDA Device · Class II · 2017-03-08 · Merge Healthcare
Reason: The software is not adding the correct tomo image. - Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge He…
FDA Device · Class II · 2017-03-01 · Merge Healthcare
Reason: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)