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U.S. Department of Health and Human Services

Class 2 Device Recall PageWriter

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  Class 2 Device Recall PageWriter see related information
Date Initiated by Firm January 09, 2019
Create Date February 21, 2019
Recall Status1 Open3, Classified
Recall Number Z-0857-2019
Recall Event ID 81957
510(K)Number K113144  
Product Classification Electrocardiograph - Product Code DPS
Product PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients
Code Information US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer 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 Determined
Cause 2		 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 57
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = PHILIPS MEDICAL SYSTEMS
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