FDA Device recall Z-2102-2018
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (includ…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (includ… by Ge Healthcare, citing potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2102-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-25 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
Reason
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Identifiers
| code_info | 102123-1-Centricity Universal Viewer-00558570, 9796-1-Centricity Universal Viewer-00558571, 1011-1-Centricity Universal…102123-1-Centricity Universal Viewer-00558570, 9796-1-Centricity Universal Viewer-00558571, 1011-1-Centricity Universal Viewer-00558109, 4433-1-Centricity Universal Viewer-00558704, 4446-2-Centricity Universal Viewer-00558643, 13240-2-Centricity Universal Viewer-00558103, 4487-1-Centricity Universal Viewer-01291589, 13295-1-Centricity Universal Viewer-01292684, 103090-2-Centricity Universal Viewer-00546048, 3760-1-Centricity Universal Viewer-00101627, 102580-1-Centricity Universal Viewer-00558689, 102143-1-Centricity Universal Viewer-00558685, 4271-1-Centricity Universal Viewer-00558351, 4273-3-Centricity Universal Viewer-00558104, 2440-1-Centricity Universal Viewer-00558701, 100366-1-Centricity Universal Viewer-00558522, 100769-1-Centricity Universal Viewer-01298556, 102278-1-Centricity Universal Viewer-00558682, 3846-3-Centricity Universal Viewer-00111167, 4449-1-Centricity Universal Viewer-00558276, 3245-1-Centricity Universal Viewer-01451973, 101690-1-Centricity Universal Viewer- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2102-2018%22
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