FDA recall Z-1923-2020

Product

Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067

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-1923-2020