The FDA announced on August 6, 2020, that Merge Healthcare, Inc. is recalling Merge PACS medical devices because measurements generated by the software may be incorrect. The agency issued recall number Z-2944-2020 for the Class II device.
How to tell if you have it
- Brand: Merge Healthcare
- Product: Merge PACS
- UPC: 00842000100805
- UDI v8.1 PACS: (01)00842000100805(10)8.1(11)191022
- UDI v8.1 OrthoPACS: (01)00842000100805(10)8.1(11)191022
- UDI v8.1.1 PACS: (01)00842000100805(10)8.1.1(11)200528
- UDI v8.1.1 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528
- UDI v8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709
The hazard
According to the FDA, measurements done on the Merge PACS generated MPRs may have incorrect measurements.
Context
GovInfoNow's records show that Merge Healthcare, Inc. has 11 other recalls on record since June 13, 2017. Other recent recalls of similar products include GE Healthcare Centricity PACS Software Recall (July 31, 2026), FUJIFILM Synapse PACS Software v7.4.310 (July 22, 2026), and GE Healthcare Centricity PACS Server V7 Recall (July 31, 2026).