Philips PageWriter TC30 ECG Devices Recalled for Overheating and Ignition Risk
Philips is recalling PageWriter TC30 ECG devices because end-of-life batteries may overheat, melt the case, 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 (melting case/ignition) to patients and users, which aligns with the rubric criteria for 'Severe' severity (significant injury/property-damage reports or structural defects).
Plain-English summary
Philips North America, LLC is recalling 13,239 units of the PageWriter TC30 (Product 860306) 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 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 devices 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 to determine if their unit is affected.
The recalled product
- Product
- PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
- Manufacturer
- Philips North America, LLC
- Affected units
- 13,239
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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