Medical device recalls Moderate risk

ProxiDiagnost N90 recalled over fire hazard

Recall date
April 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Philips North America, LLC recalls ProxiDiagnost N90, UDI 706100
Recall number
Z-2256-2020
FDA classification
Class II
Brand / firm
Philips North America, LLC
Sold / distributed
Domestic distribution nationwide. Foreign distribution to Chile and Germany.

Why it was recalled

The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo switch is not activated, the device may begin to generate smoke.

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, UDI 706100

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