Company: Philips Medical Systems, Inc.
Date of Enforcement Report 3/2/2016
Class lI:
PRODUCT
Philips Healthcare IntelliVue Info Center iX, A.0 866023 Recall Number Z-0856-2016
REASON
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5671
DISTRIBUTION
Worldwide
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