PlainRecalls
FDA Devices Moderate Class II Terminated

Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Reported: February 5, 2014 Initiated: December 9, 2013 #Z-0832-2014

Product Description

Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Reason for Recall

Patient images exhibited ring artifacts.

Details

Units Affected
7 units
Distribution
Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.
Location
Cleveland, OH

Frequently Asked Questions

What product was recalled?
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 7 units.
Why was this product recalled?
Patient images exhibited ring artifacts.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2014. Severity: Moderate. Recall number: Z-0832-2014.