X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 145 09 12 000
Date submitted: 9/19/2012
Manufacturer:Leica Microsystems Inc
Device Type:General-purpose surgical microscope, Leica M525 F50
Description:General-purpose surgical microscope
Medical Device Identifier:Serial no.: 10711001, 40112001, 130112001, 130212001, 300311002, 250311001, 300311001, 190711001, 290711001, 10811001, 310811001, 200911002, 40112002, 110112001, 310112001, 270212001, 290312001, 240312001, 300512001
Reason of Field Safety Corrective Action:Leica Microsystems evaluated data showing that a malfunction resulting in an illumination shutdown of Leica M525 F50 surgical microscope if used with a low nominal voltage power supply of 100V +/-10V (Le. 90V). A back-up (auxiliary) illumination is available if the main illumination shut off (fails) during a surgical procedure. The user can switch to the back-up (auxiliary) illumination system and the user can continue with the surgical procedure.
Remedy Action:New improvement in the cooling of the power supply by adding cooling sheets around the power supply unit. The additional cooling sheets will increase the surface of the heat sink of the xenon power supply that will compensate for an unforeseeable increased temperature due to several causes (e.g. heat resulting in inefficiency of power supply driven at continuous low nominal voltage and/or increased environmental temperature).
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCAR
Source Ref. Number:CH-2012-09-14-050
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Leica.pdf