Medical device recalls Moderate risk

Philips North America, LLC recalls ProxiDiagnost N90

Recall date
November 20, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3023-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
United States

Why it was recalled

Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

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

What was recalled

ProxiDiagnost N90

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