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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 055 12 11 000
Date submitted: 12/11/2011
Manufacturer:Philips Medical Systems
Device Type:Radiographic unit, mammographic
Description:Mammo Diagnost DR
Medical Device Identifier:714040
Reason of Field Safety Corrective Action:During in-house tests, it was found that the Mammo Diagnost DR gantry metal covers are not securely electrically connected to protective earth. All systems with production date before May 2011 are affected.
Remedy Action:The manufacturer issued the enclosed FSN. Field Safety Engineers will attach a grounding cable to the covers of the column. The corrective actions are expected to be completed before end of April 2012.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh , (01) 2119999
Report Source:NCAR
Source Ref. Number:DE-BfArM-2011-12-07-225
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments