PlainRecalls
FDA Devices Moderate Class II Terminated

Philips Brilliance 64 computed tomography x-ray system

Reported: February 14, 2018 Initiated: October 6, 2017 #Z-0518-2018

Product Description

Philips Brilliance 64 computed tomography x-ray system

Reason for Recall

Numerous issues related to software Brilliance iCT 4.1.6 software version.

Details

Units Affected
1801
Distribution
26 US Govt accounts
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
Philips Brilliance 64 computed tomography x-ray system. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 1801.
Why was this product recalled?
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0518-2018.