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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 025 01 15 000
Date submitted:	1/5/2015

Manufacturer:	Philips Healthcare
Device Type:	Philips HeartStart MRx Monitor/Defibrillator ..
Description:	Monitor/Defibrillator
Medical Device Identifier:	Product: Philips HeartStart MRx Monitor/Defibrillators Units Affected: MRx units with a serial number within the following ranges: -Model M3535A: US00100100 to US00578696 -Model M3536A: US00100902 to US00576650 -Model M3536J: US00209838 to US00332675 -Model M3536M: US00500002 to US00553553 -Model M3536MC: US00500001 to US00500087 -Model M3536M2: US00554176, US00554177, US00554178 -Model M3536M4: US00500003 to US00574869 -Model M3536M5: US00500001 to US00562935 -Model M3536M6: US00554358 to US00576619
Reason of Field Safety Corrective Action:	The MRx could reboot once in any operating mode if the following sequence occurs: 1. In Service Mode, the Status Log* is cleared 2. Prior to exiting Service Mode, the MRx generates an entry in the Status Log. 3. Service Mode is exited. The MRx is then in a state that could trigger a reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed. The MRx will restart within 8 seconds.
Remedy Action:	You can continue to use your MRx prior to receiving the software upgrade. If the MRx reboots during clinical use, continue to treat the patient according to your organization’s protocol, reinitiating therapy if necessary.
Athorized Representative/Importer/Distributor:	Philips Healthcare Saudi Arabia Ltd.
Report Source:	NCMDR
Source Ref. Number:	48B95A991A20E
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Philips Healthcare 2.pdf

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