FDA recall Z-2256-2020

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