Severe FDA (Devices)·Z-0856-2019·Announced 2019-02-27

Philips PageWriter TC20 Recall for Battery Overheating and Fire Risk

Philips is recalling PageWriter TC20 devices because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury.

What this means for you

Illness, injury, or structural failure has been reported. 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 physical injury (burns) from melting cases, which aligns with the rubric criteria for 'Severe' (significant injury reports or structural defects leading to harm).

Plain-English summary

Philips North America, LLC is recalling 14,067 units of the PageWriter TC20 (Product 860332) electrocardiograph devices. The recall covers software revisions up to and including A.07.05.22, which are used to evaluate the electrocardiogram of adult and pediatric patients.

The recall is being issued because the cardiograph batteries, which have reached the end of their 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.

The affected devices were distributed domestically nationwide and internationally worldwide. Consumers and healthcare facilities should check their inventory for the specific product codes listed in the official recall notice and follow the instructions provided by Philips to address the battery hazard.

The recalled product

Product: PageWriter TC20, Product 860332, 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
overheating
Affected units: 14,067

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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