FDA-Device2015-06-10Class II

Brilliance iCT Computed Tomography X-ray system

Philips Medical Systems (Cleveland) Inc
Hazard

A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.

Sold states
Internationally to the countries of China and Norway.
Affected count
2
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Brilliance iCT Computed Tomography X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2015

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