FDA-Device2020-06-10Class II
ProxiDiagnost N90, UDI 706100
Philips North America, LLC
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.
Sold states
Domestic distribution nationwide. Foreign distribution to Chile and Germany.
Affected count
91
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
ProxiDiagnost N90, UDI 706100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2256-2020Don't want to check this manually?
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