Novarad Corporation recalls NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Recall date

November 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1613-2016

FDA classification

Class II

Brand / firm

Novarad Corporation

Sold / distributed

Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.

Why it was recalled

The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

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  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation