Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/3/2015
Class lI:
PRODUCT
Brilliance CT Big Bore Oncology. 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.
Recall Number Z-1648-2015
REASON
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Cleveland, OH on 3/16/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
153 units
DISTRIBUTION
China
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