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Philips North America, LLC recalls ProxiDiagnost N90, UDI 706100
Recalled June 10, 2020 · FDA recall Z-2256-2020 · Philips North America
Hazard
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. · FDA Class II
Units
91
Sold at
Domestic distribution nationwide. Foreign distribution to Chile and Germany.
Description
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.
Product
ProxiDiagnost N90, UDI 706100
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →