Company: Philips Electronics North America Corporation
Date of Enforcement Report 8/10/2016
Class lI:
PRODUCT
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. 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. The monitors are intended for use by trained healthcare professionals in a hospital environment.
Recall Number Z-2328-2016
REASON
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patient s current condition.
RECALLING FIRM/MANUFACTURER
hilips Electronics North America Corporation , Andover, MA on 7/26/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
50,495
DISTRIBUTION
Nationwidewide
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