The Centricity PACS Workstation is intended for use as a primary… — Class II medical device recall Z-1665-2014
Terminated recall by GE Healthcare, reported 2014-06-04, distributed nationwide. It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the
| Recall number | Z-1665-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Barrington, IL, United States |
| Recall initiated | 2014-04-03 |
| Classified | 2014-05-28 |
| Reported by FDA | 2014-06-04 |
| Terminated | 2015-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CL, DE, ES, FR, GB, IE, IL, IN, IT, JP, KR, KW, LB, NL, SA, SE, SG, TR, TW |
| Quantity | 297 units |
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure.
Reason for recall
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in
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-1665-2014. 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.