Agency classClass IIOur severity:Severe FDA (Devices)·Z-2892-2018·Announced 2018-08-29

Philips SureSigns VSV Monitors Recalled for Battery Overheating and Ignition Risk

Philips is recalling SureSigns VSV monitors because lithium-ion batteries may overheat or ignite if not replaced on schedule, 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 meets the criteria for a Severe (Score 4) classification involving significant injury or property-damage reports.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips SureSigns VSV (Vital Signs Viewer), model 863067, due to a safety hazard involving the device's lithium-ion batteries. The recall affects units distributed worldwide, including the United States and numerous international markets. The specific issue is that batteries which have exceeded their life expectancy may overheat or ignite.

The hazard arises because the existing labeling on the monitors does not provide full instructions on how to use the displayed battery age and charge-discharge cycle data to determine when replacement is necessary. Although the devices can display this information, the lack of clear guidance may lead to batteries being used beyond their recommended lifespan of 3 years or 300 charge-discharge cycles. An overheated battery can cause the device case to melt or the device to ignite, which can result in injury to patients or nearby users and damage to property.

Healthcare facilities and users of these devices should stop using the affected monitors and contact Philips for instructions on battery replacement or device return. The recall covers specific quantities of VM, VS, and VSV units as identified by the manufacturer.

The recalled product

Product: Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the…
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Patient Monitoring
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# VSV (863067): 00884838009578

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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