FDA recall Z-0853-2019

Philips North America, LLC · Class II · device

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

Reason for recall

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.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status: Ongoing
Initiation date: 2019-01-09
Report date: 2019-02-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0853-2019