GE Healthcare Centricity PACS-IW — Class II medical device recall Z-1302-2018
Terminated recall by GE Healthcare, reported 2018-04-11, distributed nationwide. A database handling error could occur during the image acquisition process affecting the completeness of acqui
| Recall number | Z-1302-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Barrington, IL, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-04-03 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 569 units |
| Serial numbers | 00001-CENTRICITY, 06002-CENTRICITY, 100009-1-CENTRICITY, 100065-1-CENTRICITY, 100104-1-CENTRICITY, 100166-1-CENTRICITY, 100191-1-CENTRICITY, 100199-1-CENTRICITY, 100458-1-CENTRICITY, 100468-1-CENTRICITY, 100489-1-CENTRICITY, 100580-1-CENTRICITY, 100581-1-CENTRICITY, 100582-1-CENTRICITY, 100636-1-CENTRICITY, 100645-1-CENTRICITY, 100663-1-CENTRICITY, 100664-1-CENTRICITY, 100666-1-CENTRICITY, 100674-1-CENTRICITY, 100701-1-CENTRICITY, 100702-1-CENTRICITY, 100717-1-CENTRICITY, 100729-1-CENTRICITY, 100761-1-CENTRICITY and 461 more |
| Model numbers | 2049588-008, 2052831-00X |
Product
GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Reason for recall
A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.
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-1302-2018. 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.