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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