Company:Philips Medical Systems Inc.
Date of Enforcement Report 3/20/2013
Class ll:
PRODUCT
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT 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. Recall Number Z-0950-2013
REASON
This field change order is being released to update software and customer release notes to the affected installed base.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Inc., Cleveland, OH on 2/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
42 Units
DISTRIBUTION
Nationwide and Internationally
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