Agency classClass IIOur severity:Severe FDA (Devices)·Z-0858-2019·Announced 2019-02-27

Philips PageWriter TC Cardiograph Recall for Battery Overheating and Fire Risk

Philips is recalling PageWriter TC70 cardiographs 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 involves a risk of fire and injury to patients and users, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk physical hazards, warranting a Severe rating.

Plain-English summary

Philips North America, LLC is recalling the PageWriter TC70 w/o trolley Government Bundle (Product 860353) with software revisions up to and including A.07.05.22. The recall involves 2 units distributed domestically nationwide and worldwide. The devices are used to evaluate the electrocardiogram of adult and pediatric patients.

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 the patient or nearby users.

Consumers and healthcare facilities should stop using the affected devices immediately. Affected units are identified by the codes US91412044 and USO1513631. Users should contact Philips North America, LLC for instructions on how to proceed with the recall.

The recalled product

Product: PageWriter TC70 w/o trolley Government Bundle, Product 860353, 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: 2

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)

US91412044 USO1513631

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 →

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