Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/2/2016
Class lI:

PRODUCT

Philips IntelliVue Measurement Module X1 Model: M3001A. Recall Number Z-0853-2016

REASON
The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13300

DISTRIBUTION
Worldwide

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