The Centricity Universal Viewer Version is a device that displays… — Class II medical device recall Z-0226-2016
Terminated recall by GE Healthcare, reported 2015-11-11, distributed nationwide. Inaccurate distance measurements with magnified projection X-ray images.
| Recall number | Z-0226-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Barrington, IL, United States |
| Recall initiated | 2015-09-28 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2018-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CA, CH, CL, CN, DE, EC, ES, FR, GB, GH, HK, IL, IN, IT, JP, KE, KR, MT, MY, NL, SA, SE, SG, TR, TW, VE, ZA |
Product
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason for recall
Inaccurate distance measurements with magnified projection X-ray images.
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-0226-2016. 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.