Agency classClass IIOur severity:Severe FDA (Devices)·Z-0860-2019·Announced 2019-02-27

Philips PageWriter TC50 Recall for Battery Overheating and Ignition Risk

Philips is recalling PageWriter TC50 devices because end-of-life batteries may overheat, melt, or ignite, posing injury risks to patients and users.

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 is classified as FDA Class II and involves a risk of fire and physical injury to patients and users, meeting the criteria for a Severe rating.

Plain-English summary

Philips North America, LLC is recalling the PageWriter TC50 Government Bundle (Product 860429) with software revisions up to and including A.07.05.22. The recall involves three units distributed domestically nationwide and internationally worldwide.

The recall is issued because the cardiograph batteries, which have reached end of life, may overheat. This overheating can cause the device case to melt and/or the device to ignite. Such events can cause injury to patients or nearby users.

Consumers and healthcare facilities should stop using the affected devices immediately and contact Philips North America, LLC for instructions on replacement or repair. The recall is classified as Class II by the FDA.

The recalled product

Product: PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Manufacturer: Philips North America, LLC
Category: Medical Device — Cardiograph
Hazard: fire
burn-injury
Affected units: 3

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)

USN1800002 USN1800003 USN1800004

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Philips North America, LLC 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 9 products in this recall →

Same manufacturer · Philips North America, LLC

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