(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE… — Class II medical device recall Z-1566-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-08-31, distributed in AR, AZ, CA, CO, DE, FL, GA, IA…. Inaccurate Distance and Area measurements with use of Global Stack viewport.
| Recall number | Z-1566-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-07-15 |
| Classified | 2022-08-24 |
| Reported by FDA | 2022-08-31 |
| Distributed | AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AU, AW, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, DE, DO, EC, EG, ES, FR, GB, GH, HK, ID, IE, IL, IN, IQ, IT, JP, KR, KW, LB, MT, MX, MY, NL, PA, PE, PL, QA, RU, SA, SG, TH, TR, TT, TW, VN, ZA |
| Quantity | 1,690 devices |
| UPC / GTIN / UDI-DI | 00195278379610, 00840682103800, 00840682145558, 00840682145794 |
| Model numbers | 2088026-9XX, 5826659-0XX, 5865740-00X |
Product
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Reason for recall
Inaccurate Distance and Area measurements with use of Global Stack viewport.
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-1566-2022. 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.