Agency classClass IIOur severity:Severe FDA (Devices)·Z-2894-2018·Announced 2018-08-29

Philips SureSigns VS4 Vital Signs Monitor Recalled for Battery Fire Risk

Philips is recalling SureSigns VS4 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage 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 criteria for 'Severe' (significant injury/property-damage reports or structural defect).

Plain-English summary

Philips Electronics North America Corporation is recalling the SureSigns VS4 Vital Signs Monitor (models 863283 and 863286) due to a safety hazard involving the lithium-ion batteries. The recall covers 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 was initiated after Philips received reports that monitors with lithium-ion batteries that had exceeded their life expectancy 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 using these devices should check the battery status and follow Philips' instructions for replacement or device return.

The recalled product

Product: 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…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Patient 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 (1)

UDI# VS4 (863283): 00884838087095

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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