FDA Device recall Z-2151-2016
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer
- FDA Device
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer by Novarad, citing potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2151-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-09 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Novarad |
| Distribution | US |
Product
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Reason
Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
Identifiers
| code_info | All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0 |
|---|
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-2151-2016%22
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