FDA recall Z-2256-2020

Philips North America, LLC · Class II · device

Product

ProxiDiagnost N90, UDI 706100

Reason for recall

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.

Distribution

Domestic distribution nationwide. Foreign distribution to Chile and Germany.

Key facts

Status
Terminated
Initiation date
2020-04-23
Report date
2020-06-10
Termination date
2023-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2020