Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/17/2016
Class lI:
PRODUCT
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Recall Number Z-2382-2016
REASON
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP 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
57 Units
DISTRIBUTION
Nationwide and Internationally
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