FDA-Device2016-08-10Class II
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.
Philips Electronics North America Corporation
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
Sold states
Worldwide Distribution - US Nationwide
Affected count
50,495
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2328-2016Don't want to check this manually?
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