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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 145 07 16 000
Date submitted: 7/26/2016
Manufacturer:Hologic Inc
Device Type:Dimensions 8000 Acquisition Workstation
Description:Mammography
Medical Device Identifier:All machines (Dimensions 8000) which are descending below serial No. 81004154758 and located in Saudi Arabia
Reason of Field Safety Corrective Action:Dimensions 8000 Acquisition Workstation which under certain conditions may allow very low level secondary scatter radiation to pass through to the operator.
Remedy Action:Installation of front and back internal x-ray shield for the Dimensions 8000 Acquisition workstation
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:301D429B961C0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hologic.pdf