Agency classClass IIOur severity:Severe FDA (Devices)·Z-2896-2018·Announced 2018-08-29

Philips SureSigns VS2 Monitor Recall for Battery Overheating and Ignition Risk

Philips is recalling SureSigns VS2 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and injury to patients and property, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk hazards, warranting a Severe classification.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips SureSigns VS2 vital signs monitor (models 863079, 863080, 863081, 863082, 863283, and 863286). The recall involves approximately 96,324 VM units, 110,424 VS units, and 691 VSV units distributed worldwide, including the United States and numerous international markets.

The recall is due to reports that monitors with lithium-ion batteries that exceeded their life expectancy have overheated or ignited. These batteries are designed to be replaced every three years or after 300 charge-discharge cycles. While the monitors can display battery age and cycle counts, the existing labeling does not provide full instructions on how to use this data to determine when replacement is necessary.

An overheated battery can cause the device case to overheat, melt, or ignite, which may result in injury to patients or nearby users and damage to property. Healthcare professionals should check the battery status of their devices and follow Philips' instructions for replacement or repair to mitigate these risks.

The recalled product

Product: Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameter of patients. Standard and optional parameters…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Vital Signs Monitor
Hazard: fire
burn-injury
property-damage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

UDI# VS2 (863079): 00884838009639
(863080): 00884838009646
(863081): 00884838009653
(863082): 00884838009660

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

See all →

High
Philips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26
Moderate
Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall
FDA (Devices) · 2018-12-19
High
Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk
FDA (Devices) · 2018-10-03
High
Philips Allura Xper FD2O Ceiling Monitor Suspension Recall
FDA (Devices) · 2018-10-03
High
Philips AlIura Xper F010 F Monitor Ceiling Suspension Recall
FDA (Devices) · 2018-10-03

Same hazard · fire