Severe FDA (Devices)·Z-0853-2019·Announced 2019-02-27

Philips PageWriter TC70 Cardiograph Recall for Battery Overheating Risk

Philips is recalling PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt the case, or ignite, posing a risk of injury to patients and users.

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 is classified as FDA Class II and involves a risk of fire and injury, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or structural defects.

Plain-English summary

Philips North America, LLC is recalling 15,064 units of the PageWriter TC70 cardiograph (Product 860315). The recall covers devices with 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 batteries in these devices that have reached the end of their life may overheat. This overheating can cause the device case to melt and/or the device to ignite, which can cause injury to the patient or nearby users.

The affected units were distributed domestically nationwide and internationally worldwide. Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice and contact Philips for instructions on how to proceed.

The recalled product

Product: PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Manufacturer: Philips North America, LLC
Category: Medical Device — Cardiograph
Hazard: fire
burn-injury
Affected units: 15,064

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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