FDA Device recall Z-2502-2021
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from var…
- FDA Device
- Class II
- ongoing
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from var… by Ge Healthcare, citing image acquisition failures and synchronization failure with the Centricity Enterprise Archive.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2502-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-06 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV, WY |
Product
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
Reason
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Identifiers
| code_info | 2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 08305…2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2502-2021%22
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