Recall Z-0859-2019— Philips North America, LLC

Name: FDA recall Z-0859-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-09

Class II · Ongoing

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-01-09. It names one FDA 510(k) clearance: K113144. Product: PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients. 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-01-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113144 — PAGEWRITER TC 20, 30, 50, 70Philips Medical Systems·cleared 2012-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.