Home / Recalls / Medical Devices
Philips North America Llc recalls IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage:
Recalled June 2, 2021 · FDA recall Z-1671-2021 · Philips North America
Hazard
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices · FDA Class II
Units
3 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Description
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
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.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →