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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 052 04 12 000
Date submitted: 4/11/2012
Manufacturer:Philips Healthcare
Device Type:Monitor/defibrillator, Philips HeartStart MRx
Description:Monitor/defibrillator
Medical Device Identifier:Model M3536A with software version R.01.00, R.02.00 or R.03.01.
Reason of Field Safety Corrective Action:May experience unexpected power cycling (system reboot) during device power on (startup). Some devices have been observed to experience rebooting cycles for up to five minutes before the MRx stabilizes.
Remedy Action:Installation of updated software on affected devices.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:0B2FF3E31E22E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf