Company: Philips Medical Systems, Inc.
Date of Enforcement Report 6/18/2014
Class lI:
PRODUCT
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
Recall Number Z-1783-2014
REASON
If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patients monitored on that device. If the primary server reboots, all patients across all iX devices will be impacted.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Andover, MA on 3/5/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
899
DISTRIBUTION
Nationwide and Canada
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