Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/202016
Class lI:
PRODUCT
Ingenuity CT 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-1356-2016
REASON
The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices..
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 2/5/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
82 Units
DISTRIBUTION
Nationwide and Internationally
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