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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 029 01 19 000
Date submitted: 1/10/2019
Manufacturer:Philips Healthcare
Device Type:Philips PageWriter TC Cardiographs (TC20/30/50/70)
Description:Electrocardiographs, Multichannel
Medical Device Identifier:Product Codes: 860315, 860310, 860306, 860332, 860352, 860353, 860354, 860355, 860429
Reason of Field Safety Corrective Action:Philips has received a report in which the lithium ion battery in a Philips PageWriter TC cardiograph overheated and ignited.
Remedy Action: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. You will be notified when the customer installable software update is available.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:5BACF7BD122CD
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf