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Merge Healthcare, Inc. FDA Recalls
10 recalls on file across devices, 0 of them Class I and 9 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationClass IIJul 22, 2026Software issue may cause measurements to be displayed inaccu |
| Merge OrthoPACS, medical imaging diagnostic workstationClass IIJun 30, 2026Thumbnails from a previously opened patient study may be dis |
| Merge PACS, medical imaging diagnostic workstationClass IIJun 30, 2026Thumbnails from a previously opened patient study may be dis |
| Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The MClass IIAug 11, 2025Merge Healthcare has been informed by Schiller AG (Baar, Swi |
| 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 VClass IIFeb 19, 2025When following a specific less typical workflow in which the |
| 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 , 1Class IIFeb 19, 2025When following a specific less typical workflow in which the |
| VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated caClass IIFeb 19, 2025When following a specific less typical workflow in which the |
| VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrateClass IIFeb 19, 2025When following a specific less typical workflow in which the |
| 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, 12Class IIFeb 19, 2025When following a specific less typical workflow in which the |
| Merge Hemo, Software packages 10.2, 10.3, and 10.4Class IIJul 23, 2021The firm identified a safety issue affecting the software as |