FDA recall Z-1774-2021

Philips North America Llc · Class II · device

Product

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306

Reason for recall

Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury

Distribution

Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.

Key facts

Status
Terminated
Initiation date
2021-04-13
Report date
2021-06-09
Termination date
2022-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2021