FDA Device recall Z-2944-2020
Merge PACS
- FDA Device
- Class II
- terminated
- Published 2020-09-16
On 2020-09-16 the FDA classified a Class II recall of Merge PACS by Merge Healthcare, citing measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2944-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-06 |
| Published | 2020-09-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merge Healthcare |
| Distribution | AR, CA, CT, DE, FL, GA, IL, IN, MD, MI, MN, MO, MS, NC, ND, NE, NH, NM, NY, OH, SC, TX, UT, VA, WI |
Product
Merge PACS
Reason
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Identifiers
| code_info | Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(…Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2944-2020%22
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