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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 046 03 17 000
Date submitted: 3/9/2017
Manufacturer:Olympus
Device Type:SPL-G – SHOCKPULSE GENERATOR
Description:Lithotripsy System, Stone Eliminator
Medical Device Identifier:All serial numbers prior to CG0196
Serial numbers CG0201 - CG0204
All serial numbers starting DG
Reason of Field Safety Corrective Action:The manufacturer of the ShockPulse generator, Cybersonics Inc, produced the product in accordance with IEC60601-1 standard, with an independent laboratory successfully certifying the system. However, more recent testing has identified that under certain conditions one of the test criteria (Touch Current under single fault condition) has the potential to exceed the standard.
Remedy Action:An Olympus representative will contact you shortly to have your system returned to olympus service centre for a free electronics upgrade.
Athorized Representative/Importer/Distributor:Salehiya Trading Est.
Report Source:NCMDR
Source Ref. Number:1E8A64C91E1F3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Olympus.pdf