FDA recall Z-1922-2020

Philips North America, LLC · Class II · device

Product

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

Reason for recall

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Distribution

Worldwide distribution including one unit distributed to Iowa.

Key facts

Status
Terminated
Initiation date
2020-04-06
Report date
2020-05-13
Termination date
2022-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1922-2020