FDAJanuary 9, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear