Data Foundry

Medical device recalls 2021

Centricity Universal Viewer and Viewer 6 — Class II medical device recall Z-2503-2021

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 numberZ-2503-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Healthcare, LLC, Waukesha, WI, United States
Recall initiated2021-08-06
Classified2021-09-22
Reported by FDA2021-09-29
DistributedAK, 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 USAT, BR, CA, CH, DE, ES, FR, GB, GH, IE, IL, IN, IT, KW, NL, PA, PL, RU, SA, SI, TR, UY, ZA
UPC / GTIN / UDI-DI00840682103800
Model numbers2088026-723, 2090255-001, 2102676-001, 2104867-044

Product

Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Includes the following Model Numbers: 1. Model Number: 2090255-001; 2. Model Number: 2088026-723; 3. Model Number: 2102676-001; 4. Model Number: 2104867-044.

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-2503-2021. 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.