Philips North America, LLC recalls PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogra

Recalled February 27, 2019 · FDA recall Z-0853-2019 · Philips North America

Hazard

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. · FDA Class II

Units

15,064

Sold at

Domestic distribution nationwide. Foreign distribution worldwide.

Description

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.

Product

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Manufacturer(s)

Philips North America, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →