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Recall Observatory FDA recall evidence

Device product

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

Z-0858-2019

January 09, 2019

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 81957
Status
Ongoing
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0858-2019

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: US91412044 USO1513631

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.