FDA Device

Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.

Hazard

Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.

What You Should Do

Remedy

Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.

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Products

Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.
Brand
Philips Medical Systems (Cleveland) Inc
UPC
Model No. 728231. Version 2.2.1

Units Affected

404

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