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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 109 01 12 000
Date submitted: 1/30/2012
Manufacturer:Leica Microsystems Inc.
Device Type:Ophthalmic surgical microscope
Description:Ophthalmic, microscope
Medical Device Identifier:Leica M822 F20 and Leica M822 F40 Software version: MDC 3.5
Reason of Field Safety Corrective Action:It was identified that the malfunction (locks up) occurs in the zoom function of the Leica M822.
Remedy Action:The device has been designed with a zoom back-up system (e.g. manual adjustment of zoom). As described in the user manual (Art. # 10 743 504, Version -, page 37 and page 63), in case the zoom cannot be adjusted electrically, the zoom can be adjusted manually by pushing and turning the zoom rotary knob to adjust the zoom manually. The root cause of the malfunction is a software bug in MDC Software Version 3.5. Upgrade of new software in all affected device to correct the malfunction and to prevent the malfunction to occur again
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCAR
Source Ref. Number:CH-2012-01-24-004
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments