medical Class II Updated 2019-02-27

Philips North America, LLC recalls PageWriter TC50 Government Bundle, Product 860429, Software

Recalled Product

PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients


Hazard / Issue

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: USN1800002 USN1800003 USN1800004
View official government recall

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