Company: Philips Medical Systems, Inc.
Date of Enforcement Report 2/4/2015
Class lI:
PRODUCT
BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
Recall Number Z-1011-2015
REASON
Unintended detector and gantry movement due to software issues.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Cleveland, OH 11/12/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1064
DISTRIBUTION
Nationwide and Internationally
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