—#170421

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

FDA product code: DPS — Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113144
Affected lot / code info: US91412044 USO1513631

Why it was 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.

Root cause (FDA determination)

Use error

Action the firm took

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).

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.

Timeline

Recall initiated: 2019-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170421. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.