Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/18/2014
Class lI:
PRODUCT
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Recall Number Z-1746-2014
REASON
IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Andover, MA on 5/22/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
42,600
DISTRIBUTION
Nationwide and Internationally
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