The Centricity PACS Workstation is intended for use as a primary… — Class II medical device recall Z-1214-2015
Terminated recall by GE Healthcare, reported 2015-03-04, distributed nationwide. Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc)
| Recall number | Z-1214-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Barrington, IL, United States |
| Recall initiated | 2013-02-18 |
| Classified | 2015-02-26 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM |
| Quantity | 128 systems |
| 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
Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
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-1214-2015. 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.