Skip to content
Recall Observatory FDA recall evidence

Device product

PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Z-0860-2019

January 09, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 81957
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0860-2019

Official wording

Reason: 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.

Code information: USN1800002 USN1800003 USN1800004

Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.