FDA Device recall Z-0226-2016
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sourc…
- FDA Device
- Class II
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class II recall of The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sourc… by Ge Healthcare, citing inaccurate distance measurements with magnified projection X-ray images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0226-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-28 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason
Inaccurate distance measurements with magnified projection X-ray images.
Identifiers
| code_info | 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0226-2016%22
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