Agency classClass IIOur severity:Severe FDA (Devices)·Z-0857-2019·Announced 2019-02-27

Philips PageWriter TC70 Cardiograph Recall for Battery Overheating Risk

Philips is recalling 57 PageWriter TC70 cardiographs because end-of-life batteries may overheat, melt, or ignite, posing a risk of injury 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 physical injury (melting/ignition) to patients and users, which aligns with the 'Severe' criteria for significant injury reports or high-risk physical hazards.

Plain-English summary

Philips North America, LLC is recalling 57 units of the PageWriter TC70 w/trolley Government Bundle (Product 860352) with software revisions up to and including A.07.05. 22. These devices are used to evaluate the electrocardiogram of adult and pediatric patients.

The recall is due to a safety hazard where batteries 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 stop using the affected devices and contact Philips for further instructions on the recall.

The recalled product

Product: PageWriter TC70 w/trolley Government Bundle, Product 860352, 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: 57

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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