Medical device recalls Moderate risk

Virtual Radiologic Corp. recalls vRad PACS with Mammography

Recall date
May 9, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2235-2023
FDA classification
Class II
Brand / firm
Virtual Radiologic Corp.
Sold / distributed
US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.

Why it was recalled

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

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

What was recalled

vRad PACS with Mammography

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