FDA recall Z-0403-2018

Philips Medical Systems (Cleveland) Inc · Class II · device

Product

Brilliance iCT - Model 728306 Computed Tomography X-ray systems

Reason for recall

Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.

Distribution

Worldwide distribution, including US nationwide.

Key facts

Status: Terminated
Initiation date: 2017-07-11
Report date: 2018-01-31
Termination date: 2019-07-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0403-2018