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Medical Devices Sector
قطاع الأجهزة الطبية
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NCAR Recall
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Reference Number:
mdprc 075 01 13 000
Date submitted:
1/21/2013
Manufacturer:
Leica Microsystems Inc.
Device Type:
Neurosurgical microscope, Leica M720 OH5, Leica M525 OH4
Description:
Neurosurgical microscope
Medical Device Identifier:
Software version: MMC version 1.13; Serial no.: See attached
Reason of Field Safety Corrective Action:
There is a potential risk that a malfunction resulting in blocked inoperative A-B-C brakes can be observed.
Remedy Action:
DISCONTINUE USE until your system has had an upgrade to eliminate the potential risk. Your Leica Microsystems representative will contact you to make the necessary arrangements to complete an upgrade at no charge to you.
Athorized Representative/Importer/Distributor:
Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:
NCAR
Source Ref. Number:
CH-2013-01-14-004
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
CH-2013-01-14-004_Leica_Microsystems_Schweiz_AGVk_20130110_03_e1.pdf
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