Agency classClass IIOur severity:Severe FDA (Devices)·Z-2893-2018·Announced 2018-08-29

Philips SureSigns VS3 Vital Signs Monitor Recall for Battery Fire Risk

Philips is recalling SureSigns VS3 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 source text explicitly states that batteries have 'overheated or ignited' and that this 'can cause injury to a patient, nearby users, or cause damage to property.' This aligns with the rubric criterion for 'significant injury/property-damage reports' and 'structural vehicle defect' (analogous to a critical component failure in a medical device), warranting a score of 4.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips SureSigns VS3 Vital Signs Monitor (models 863069, 863070, 863071, 863072, 863073, and 863074). The recall involves approximately 96,324 VM units, 110,424 VS units, and 691 VSV units distributed worldwide, including the United States and Puerto Rico.

The recall is due to reports that lithium-ion batteries in these monitors have overheated or ignited after exceeding their life expectancy. While the monitors can display battery age and charge-discharge cycles, the existing labeling does not provide full instructions on how to use this information to determine when to replace the battery. An overheated battery can cause the device case to melt or the device to ignite, which may injure patients or nearby users or damage property.

Healthcare facilities should check the battery status of these monitors and follow Philips' instructions for replacement. The batteries are intended to be replaced every 3 years or upon reaching 300 charge-discharge cycles.

The recalled product

Product: Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Vital Signs Monitor
Hazard: fire
burn-injury
overheating

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 (6)

UDI# VS3 (863069): 00884838000094
(863070): 00884838000100
(863071): 00884838000117
(863072): 00884838000124
(863073): 00884838000131
(863074): 00884838000148

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

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