Medical device recalls Moderate risk

Novarad Corporation recalls NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving an…

Recall date
May 9, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2151-2016
FDA classification
Class II
Brand / firm
Novarad Corporation
Sold / distributed
Worldwide distribution including US nationwide. No Canadian distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

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