FDAJuly 13, 2018device

Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple ...

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

The hazard

Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.

What to do

FDA enforcement status: Ongoing

Brands named

philips electronics north americaphilipsphilips electronics

UPCs

00884838087095863283863286

Recall history

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

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