Philips PageWriter TC50 ECG Devices Recalled for Overheating and Fire Risk
Philips is recalling PageWriter TC50 electrocardiogram devices because end-of-life batteries may overheat, melt the case, 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 to patients and users, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk hazards in medical devices.
Plain-English summary
Philips North America, LLC is recalling 11,332 units of the PageWriter TC50 (Product 860310) electrocardiogram devices. The recall affects 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 conducted because the devices' 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 stop using the affected devices and contact Philips for instructions on how to proceed with the recall.
The recalled product
- Product
- PageWriter TC50, Product 860310, 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
- Affected units
- 11,332
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.
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