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 injury from overheating batteries, which aligns with the rubric criterion for significant injury reports or structural defects.
Plain-English summary
Philips North America, LLC is recalling the PageWriter TC30 w/ trolley Government Bundle (Product 860354) with software revisions up to and including A.07.05.22. The recall involves 7 units that were distributed domestically nationwide and worldwide.
The recall is due to a safety hazard where batteries that have reached end of 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.
Affected units are identified by the following codes: US41510645, US41510646, US71630792, USN1206382, USN1206383, USN1409879, and USO1631023. Users should contact the recalling firm for instructions on how to address this issue.
The recalled product
- Product
- PageWriter TC30 w/ trolley Government Bundle, Product 860354, 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
- Affected units
- 7
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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