Z-0860-2019Class II

PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to...

Name: Z-0860-2019 PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to...
Creator: Philips North America, LLC
Published: 2019-01-09
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-01-09 / Open, Classified

FDA source

Philips North America, LLC began a recall of PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric... on 2019-01-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0860-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-09
Posted: 2019-02-21
Recalling firm: Philips North America LLC
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
Product code: DPS Electrocardiograph
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.
FDA root cause: Use error
Action: On December 8, 2018, Philips issued an Urgent Medical Device Correction letter to its customers, informing them of the product issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction/Field Safety Notice This includes requesting that users: Carefully read the PageWriter TC Service Manual Addendum and to review this information with all staff members who are responsible for device management of the Philips PageWriter TC cardiographs Promptly determine the number of cycles and the State of Health (SOH) on each of the affected Philips PageWriter TC cardiographs (TC20/30/50/70), as specified in the Service Manual Addendum. Replace the battery if the number of cycles is greater than 300 and/or if the SOH is less than 80. Customers are instructed to complete and return the response card provided with the notice. Philips is instructing customers that once it is determined the battery is not in need of replacement, or once the battery is replaced, the PageWriter PC Cardiograph is safe to continuing using. Philips plans to release a customer installable, software update for PageWriter TC cardiograph (TC20/30/50/70) that will provide alerts to assist users in managing the battery replacement cycle. Users will be notified when the customer installable software update is available. The software will provide notification the customer when it is time to replace the battery, based on charge-discharge cycle count and the batteries state of health (SOH).
Quantity in commerce: 3
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: USN1800002 USN1800003 USN1800004

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0860-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0853-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0854-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0855-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0856-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0857-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0858-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0859-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0860-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21
Z-0861-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-27	2019-02-21

Product code DPS

K113144Class IIPagewriter Tc 20, 30, 50, 70Philips Medical Systems / cleared 2012-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)