Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/8/2016
Class lI:
PRODUCT
Ingenuity Core Computed Tomograph X-ray Systems, Product Usage: 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-1873-2016
REASON
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 4/8/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
300
DISTRIBUTION
Nationwide and Internationally
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