FDAClass IIFebruary 27, 2019

PageWriter TC70 w/o trolley Government Bundle recall

PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of…

Why was PageWriter TC70 w/o trolley Government Bundle recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

US91412044 USO1513631

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…
Recalling firm
Philips North America, LLC
Quantity
2
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Recall date
February 27, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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