Company: Philips Medical Systems, Inc.
Date of Enforcement Report 10/29/2014
Class lI:
PRODUCT
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Recall Number Z-0104-2015
REASON
Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc ,Andover, MA on 10/3/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7587 units
DISTRIBUTION
Nationwide and Internationally
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