Company: Philips Electronics North America Corporation
Date of Enforcement Report 10/26/2016
Class lI:
PRODUCT
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Recall Number Z-0292-2017
REASON
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
RECALLING FIRM/MANUFACTURER
hilips Electronics North America Corporation , Andover, MA on 10/20/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1824 units
DISTRIBUTION
Nationwidewide and Internationally
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