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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 100 02 14 000
Date submitted: 2/17/2014
Manufacturer:Philips Healthcare
Device Type:HeartStart MRx Defibrillator/Monitor
Description:Monitor, Defibrillator, Lithium Ion batteries
Medical Device Identifier:Product: Philips HeartStart MRx Lithium Ion batteries

Model: M3538A

serial numbers: 11327-0019-P, 11315-0023-P, 11315-0027-P, 11315-0031-P, 11315-0032-P, 11315-0033-P, 11315-0036-P, 11315-0109-P, 11315-0214-P, 11315-0219-P, 11315-0391-P, 11322-0084-P, 11322-0088-P, 11327-0043-P, 11327-0044-P

Or within the following range: 11335-xxxx-P to 13214-xxxx-P
Reason of Field Safety Corrective Action:External Li-Ion battery shuts down due to exposure to elevated levels of electromagnetic interference from RF energy sources.
Remedy Action:Customers will be provided with a replacement battery(s) as soon as new production is available.

The condition can be avoided by operating the device on AC or external DC power or by following actions when operating a battery power.

a) Before placing an MRx into use insert a fully charged MRx battery with illuminated LEDs on the battery fuel gauge.

b) If an MRx device in use does not power on, press the fuel gauge button on battery and verify that the LEDs are illuminated. If there are not or dimly illuminated LEDs, insert a fully charge MRx battery.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, (011) 2114547
Report Source:NCMDR
Source Ref. Number:61AB24E71322A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips.pdf