Company: Philips Medical Systems, Inc.
Date of Enforcement Report 12/14/2016
Class lI:
PRODUCT
Ingenuity CT 728326 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Recall Number Z-0697-2017
REASON
Software error due to the filament on timer.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 11/12/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
371
DISTRIBUTION
Nationwide and Internationally
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