Company: Philips Medical Systems
Date of Enforcement Report:12/195/2007
Class:ll
PRODUCT
Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008
REASON
Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated November 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide and Internationally