Company: Philips Medical Systems, Inc.
Date of Enforcement Report 12/3/2014
Class lI:
PRODUCT
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030
Recall Number Z-0473-2015
REASON
Software defect
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH 11/9/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
32
DISTRIBUTION
Nationwide and Internationally
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