FDAFebruary 2, 2021device

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 i...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

0088483808223600884838030350

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 i... — Recall Details · AllClear