Data Foundry

Medical device recalls 2016

NovaPACS  versions 7 — Class II medical device recall Z-2151-2016

Terminated recall by Novarad Corporation, reported 2016-07-20, distributed nationwide. Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

Recall numberZ-2151-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNovarad Corporation, American Fork, UT, United States
Recall initiated2013-05-09
Classified2016-07-11
Reported by FDA2016-07-20
Terminated2016-12-01
DistributedNationwide (US)
Quantity2,695

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 for recall

Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

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-2151-2016. 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.