FDA-Device2019-02-27Class II
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Philips North America, LLC
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
15,064
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0853-2019Don't want to check this manually?
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