PlainRecalls
FDA Devices Moderate Class II Terminated

Brilliance iCT Computed Tomography X-ray system

Reported: June 10, 2015 Initiated: April 13, 2015 #Z-1695-2015

Product Description

Brilliance iCT Computed Tomography X-ray system

Reason for Recall

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

Details

Units Affected
2
Distribution
Internationally to the countries of China and Norway.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
Brilliance iCT Computed Tomography X-ray system. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 2.
Why was this product recalled?
A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1695-2015.