Agency classClass IIOur severity:Severe FDA (Devices)·Z-2895-2018·Announced 2018-08-29

Philips SureSigns Patient Monitors Recalled for Battery Overheating and Ignition Risk

Philips is recalling SureSigns VM, VS, and VSV patient 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) and the agency's Class II classification.

Plain-English summary

Philips Electronics North America Corporation is recalling Philips SureSigns VM 3/4/6/8 Patient Monitors, SureSigns VS Monitors, and View Station (VSV) units. The recall involves 96,324 VM units, 110,424 VS units, and 691 VSV units distributed worldwide, including the United States and numerous international countries.

The recall is due to reports that lithium-ion batteries in these monitors have overheated or ignited after exceeding their expected life. These batteries are designed to be replaced every three years or after 300 charge-discharge cycles. While the devices can display battery age and cycle counts, the existing labeling lacks 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. This poses a risk of injury to patients or nearby users and can cause damage to property. Health care professionals should check the battery status of their devices and follow Philips' instructions for replacement or repair.

The recalled product

Product: Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the…
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 (8)

UDI#'s VM3 (863077): 00884838028791 VM4 (863063): 00884838000032
(863085): 00884838028807 VM6 (863064): 00884838000049
(863065): 00884838000056
(863086): 00884838028814 VM8 (863066): 00884838000063
(863068): 00884838000087
(863087): 00884838028821
(863088): 00884838028838
(863317): 00884838050464

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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