Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:
PRODUCT
Brilliance CT 16 Power Computed Tomography X-ray systems X-ray systems is 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-2370-2016
REASON
Software defect causing intermittently slow response of Host.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide and Internationally
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