PageWriter TC30 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 TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of…

Recall number

Z-0855-2019

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 TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients