Medical device recalls Moderate risk

Synaptive Medical Inc recalls ClearCanvas RIS/PACS

Recall date
February 26, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1758-2020
FDA classification
Class II
Brand / firm
Synaptive Medical Inc
Sold / distributed
US

Why it was recalled

A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.

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

What was recalled

ClearCanvas RIS/PACS

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