Philips North America Llc recalls IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 8
Recalled Product
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: 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.
Hazard / Issue
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Issued by
FDA
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