PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 10, 2016 Initiated: July 26, 2016 #Z-2328-2016

Product Description

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.

Reason for Recall

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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

Details

Units Affected
50,495
Distribution
Worldwide Distribution - US Nationwide
Location
Andover, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Philips Electronics North America Corporation. Units affected: 50,495.
Why was this product recalled? ▼
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2328-2016.

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