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Philips Electronics North America Corporation recalls IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever t
Recalled August 10, 2016 · FDA recall Z-2328-2016 · Philips Electronics North America
Hazard
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition. · FDA Class II
Units
50,495
Sold at
Worldwide Distribution - US Nationwide
Description
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
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.
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →