Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW… — Class II medical device recall Z-2102-2018
Terminated recall by GE Healthcare, reported 2018-06-13, distributed nationwide. Potential that one or more image series may be missing from an exam without a user warning displayed in the Vi
| Recall number | Z-2102-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Chicago, IL, United States |
| Recall initiated | 2018-01-25 |
| Classified | 2018-06-06 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2023-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BR, CA, CH, CO, DE, ES, FR, GH, IE, IL, IN, IT, KW, MX, MY, NL, PA, PL, RU, SA, TR, UY, ZA |
| Quantity | 252 |
Product
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason for recall
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
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-2102-2018. 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.