GE Centricity PACS Workstation — Class II medical device recall Z-2579-2016
Terminated recall by GE Healthcare It, reported 2016-08-24, distributed nationwide. While merging exams in a test instance, merges carry forward in the production system, when the middle tier is
| Recall number | Z-2579-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare It, Barrington, IL, United States |
| Recall initiated | 2012-11-15 |
| Classified | 2016-08-17 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BM, CA, CH, DE, DK, EG, ES, FR, GB, HK, IE, IN, IT, KR, KW, MT, NL, PT, QA, SA, SE, TH, TR, ZA |
| Quantity | 498 units |
Product
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
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-2579-2016. 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.