medical Class II Updated 2019-02-27

Philips North America, LLC recalls PageWriter TC30 w/o trolley Government Bundle, Product 86035

Recalled Product

PageWriter TC30 w/o trolley Government Bundle, Product 860355, 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: US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461
View official government recall

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