Agency classClass IIOur severity:Severe FDA (Devices)·Z-0861-2019·Announced 2019-02-27

Philips PageWriter TC30 Cardiograph Recall for Battery Overheating Risk

Philips is recalling PageWriter TC30 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 physical injury to patients and users, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk hazards.

Plain-English summary

Philips North America, LLC is recalling 14 units of the PageWriter TC30 w/o trolley Government Bundle (Product 860355). The affected devices use software revisions up to and including A.07.05.22 and are used to evaluate the electrocardiogram of adult and pediatric patients.

The recall is issued because the cardiograph batteries have reached end of life and 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 worldwide. Consumers and healthcare facilities should stop using the affected devices and contact Philips North America, LLC for further instructions.

The recalled product

Product: PageWriter TC30 w/o trolley Government Bundle, Product 860355, 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: 14

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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