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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 035 12 12 000
Date submitted: 12/5/2012
Manufacturer:Radiometer Medical
Device Type:Monitors, Bedside, Blood Gas, TCM4 series Base Unit
Description:Monitors, Bedside, Blood Gas
Medical Device Identifier:• All TCM4 series Base Units with serial numbers starting with: 000-154, 391-876, 391-878. • TCM4 series Base Unit with serial numbers of 391-880 below R0175N009. • Spare part Power Supply, 910-246.
Reason of Field Safety Corrective Action:Radiometer have recently become aware that there is a potential risk of electrical shock for the operator. The electrical shock may appear under the following conditions: • The monitor is connected to the mains outlet and the mains switch is ON • The battery is fully charged (or no battery is present) • The operator disconnects the line cord (at either end) without first switching the mains switch on the back of the monitor OFF • The operator touches the two metal pins on the mains plug or on the monitor’s line cord receptacle after disconnecting the line cord.
Remedy Action:Replace the existing Line cord receptacle by one including a discharging resistor in all affected Base Units. Please refer to separate instructions “Exchange of line cord receptacle”.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCMDR
Source Ref. Number:5185497E141B1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments