Centricity PACS-IW with Universal Viewer — Class II medical device recall Z-2502-2021
Ongoing recall by GE Healthcare, LLC, reported 2021-09-29, distributed in AK, AZ, CA, CO, DE, FL, GA, IA…. Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
| Recall number | Z-2502-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Distributed | 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 |
| Countries outside the US | AT, BR, CA, CH, DE, ES, FR, GB, GH, IE, IL, IN, IT, KW, NL, PA, PL, RU, SA, SI, TR, UY, ZA |
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 for recall
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2502-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.