CLASS II ONGOING Device recall · Reported 27 Feb 2019 · FDA Enforcement Report

PageWriter TC50 Government Bundle, Product recalled

Philips North America is recalling PageWriter TC50 Government Bundle, Product 860429, distributed nationwide in the US. The recall was initiated on 9 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUSN1800002 USN1800003 USN1800004

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0860-2019
FDA event ID: 81957
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jan 2019
FDA classified: 21 Feb 2019
Reported: 27 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

9 Jan 2019	Recall initiated by company
21 Feb 2019	Classified by FDA	+43 days
27 Feb 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Domestic distribution nationwide. Foreign distribution worldwide.

Nationwide

Questions about this recall

Is PageWriter TC50 Government Bundle, Product 860429 recalled?

Yes. Philips North America recalled PageWriter TC50 Government Bundle, Product 860429 on 9 Jan 2019. The recall is Class II and its status is Ongoing. Recall number Z-0860-2019.

Why was it 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.

Which lots are affected?

USN1800002 USN1800003 USN1800004

Where was it sold?

Domestic distribution nationwide. Foreign distribution worldwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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