Agency classClass IIOur severity:Severe FDA (Devices)·Z-1628-2014·Announced 2014-05-28

Philips Recalls Lithium Ion Batteries for IntelliVue Patient Monitors

Philips Medical Systems is recalling specific lithium ion batteries for IntelliVue Patient Monitors because they may overheat, ignite, or explode after extended use.

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 explosion (ignition/explosion) associated with a Class II medical device, which aligns with the rubric criteria for 'Severe' severity involving significant injury or property damage risks.

Plain-English summary

Philips Medical Systems, Inc. is recalling 188,520 Lithium Ion Batteries (models M4605A and M4607A) used with IntelliVue Patient Monitors. The recall covers devices distributed worldwide, including the United States, Canada, and various countries in Europe, Asia, and the Middle East. The affected monitors include specific product numbers such as M3002A, M8102A, and M8105A with software releases up to and including G.0.

The recall is due to a risk of battery failure that increases with age, specifically when a battery remains in use for longer than three years after the date of manufacture or exceeds 500 charge-discharge cycles. Such failures can result in overheating, which in rare cases can cause the battery to ignite or explode.

Healthcare facilities and users should identify affected batteries by checking the model numbers and usage history. Users should stop using the affected batteries and contact Philips Medical Systems for instructions on replacement or repair.

The recalled product

Product: Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Patient Monitor Battery
Hazard: fire
explosion
overheating
Affected units: 188,520

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 (12)

Patient Monitor Product numbers M3002A
M8102A
M8105A
M8001A
M8002A
M8003A
M8004A
M8027A
M8001AU
M8002AU
M8003AU
and M8004AU with software releases up to and including G.0.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Medical Systems, Inc.

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