Centricity Universal Viewer Product Usage: The Centricity Universal… — Class II medical device recall Z-2470-2015
Terminated recall by GE Healthcare, reported 2015-09-02, distributed nationwide. Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a
| Recall number | Z-2470-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Barrington, IL, United States |
| Recall initiated | 2015-08-11 |
| Classified | 2015-08-26 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, DE, FR, GB, GR, IE, IL, IN, MX, MY, PA, PL, RU, SA, TR, UY, ZA |
| Quantity | 26 systems |
Product
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.
Reason for recall
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
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-2470-2015. 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.