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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 006 07 17 000
Date submitted: 7/3/2017
Manufacturer:Leica Microsystems Inc.
Device Type:M720 + Protective Glass Holder
Description:Operating microscope
Medical Device Identifier:1) Type I, Non-SAI:
- Article number: 10 448 263
- Protective glass holder to be used: 10 448 280

2) Type II, SAI:
- Article number: 10 448 263
- Protective glass holder to be used: 10 448 483
Reason of Field Safety Corrective Action:When the M720 non-SAI optics carrier is used in combination with the protective glass holder article 10 448 483 with switched-off Brightcare the Protective glass article 10 446 058 can be heated up by the illumination light touching the plastic frame of the glass to temperatures above the acceptable temperature limits.
Remedy Action:Please ensure with your M720 customers that,
- M720 non-SAI users only use protective glass holder article 10 448 280
- M720 SAI users only use protective glass holder article 10 448 483

Please confirm that you and all concerned staff in the area of your responsibility has received, understood and will follow this information.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System
Report Source:NCMDR
Source Ref. Number:C2668CB7822ED
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Leica.pdf