PageWriter TC70 recalled over fire hazard

Recall date

January 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-0853-2019

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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