The Centricity PACS Workstation is intended for use as a primary… — Class II medical device recall Z-0116-2014
Terminated recall by GE Healthcare It, reported 2013-11-06, distributed nationwide. GE has recently become aware of potential issues due to out of context issues associated with specific workflo
| Recall number | Z-0116-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare It, Barrington, IL, United States |
| Recall initiated | 2013-06-11 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, CA, CN, DE, DK, ES, FR, GB, HK, IL, IN, IT, JP, KR, MY, NL, SA, SE, SG, TW |
| Quantity | 623 units |
| Reason classes | device malfunction |
Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, 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 with the Centricity PACS infrastructure.
Reason for recall
GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the
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-0116-2014. 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.