FDA-Device2018-02-14Class II

Philips Brilliance 64 computed tomography x-ray system

Philips Medical Systems (Cleveland) Inc
Hazard

Numerous issues related to software Brilliance iCT 4.1.6 software version.

Sold states
26 US Govt accounts
Affected count
1801
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Philips Brilliance 64 computed tomography x-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0518-2018

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