Medical DeviceSep 2, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation recall — FDA Z-3004-2026
Software issue may cause measurements to be displayed inaccurately.
Class IIFDA: OngoingMerge Healthcare, Inc.
Recall history in this database
Classification mix: Class II: 16.
Medical DeviceAug 12, 2026
Merge PACS, medical imaging diagnostic workstation recall — FDA Z-2874-2026
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceAug 12, 2026
Merge OrthoPACS, medical imaging diagnostic workstation recall — FDA Z-2875-2026
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceSep 10, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 recall — FDA Z-2518-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 26, 2025
Merge Healthcare VERICIS, Merge Cardio recall — FDA Z-1398-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 26, 2025
Merge Healthcare VERICIS, Merge Cardio recall — FDA Z-1399-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 26, 2025
Merge Cardio recall — FDA Z-1402-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 26, 2025
Merge Healthcare VERICIS, Merge Cardio recall — FDA Z-1401-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceMar 26, 2025
Merge Healthcare VERICIS, Merge Cardio recall — FDA Z-1400-2025
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…
Class IIFDA: OngoingMerge Healthcare, Inc.
Medical DeviceNov 4, 2020
Merge LIS recall — FDA Z-0289-2021
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.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceSep 16, 2020
Merge PACS recall — FDA Z-2944-2020
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceJul 1, 2020
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio recall — FDA Z-2403-2020
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…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceJul 31, 2019
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 recall — FDA Z-2063-2019
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…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceJul 31, 2019
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 recall — FDA Z-2062-2019
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…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceMar 6, 2019
Merge Healthcare The WinStation Retinal Imager, also known as Merge Eye Station recall — FDA Z-0939-2019
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…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceAug 8, 2018
Merge Unity software, formerly known as DR Systems Unity PACS software recall — FDA Z-2566-2018
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Merge Healthcare, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.