Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:
PRODUCT
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Recall Number Z-2383-2016
REASON
Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 4/29/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
276 Units
DISTRIBUTION
Nationwide and Internationally
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