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Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Clevela...

FDA Recall #Z-0832-2014 — Class II — December 9, 2013

Recall #Z-0832-2014 Date: December 9, 2013 Classification: Class II Status: Terminated

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.

Recalling Firm

Philips Medical Systems (Cleveland) Inc — Cleveland, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

7 units

Distribution

Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel.

Code Information

Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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