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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 017 07 12 000
Date submitted: 7/8/2012
Manufacturer:Pace Medical, Inc
Device Type:TEMPORARY EXTERNAL PACING, MICRO-PACE 4580
Description:TEMPORARY EXTERNAL PACING (WITHOUT DEFIBRILLATION)
Medical Device Identifier:Software version: 2.1 or 2.2
Reason of Field Safety Corrective Action:Pace Medical has reviewed two reports of a sensing anomaly.
Remedy Action:New component will prevent similar events from occurring which may affect sensing of the device. A simple change of a resistor value is required.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:UK-2012-07-03-124
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Pace Medical.pdf