medical Class II Updated 2019-02-27

Philips North America, LLC recalls PageWriter TC70 w/o trolley Government Bundle, Product 86035

Recalled Product

PageWriter TC70 w/o trolley Government Bundle, Product 860353, 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: US91412044 USO1513631
View official government recall

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