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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 071 07 17 000
Date submitted: 7/17/2017
Manufacturer:Roche Diagnostics Corp
Device Type:cobas c 501, 502 module
Description:IVD
Medical Device Identifier:Affected Instrument Part: USM cover 3
GMMI / Part No: GMMI 05400937001
cobas c 501 module (GMMI 04745914001)
cobas c 502 module (GMMI 05964067001)
Reason of Field Safety Corrective Action:Considering that cobas c 501 and cobas c 502 modules share the same hardware, Roche Diagnostics has decided to inform and request operators of both systems to perform the related maintenance task with special caution, so as to prevent further occurrence of this issue.
When the operator cleans the incubation bath or replaces cuvettes on cobas c 501 and cobas c 502 modules, during monthly maintenance, the USM cover 3 has to be removed and its two thumb screws have to be loosened.
Remedy Action:Customers are advised not to overtighten the thumb screws when replacing the cover after maintenance. When removing the screws for maintenance avoid touching the edge of the USM Cover 3.
A warning will be added to the respective Operator Manuals, which will be available by December 2017.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:7CEC4F4DE12E5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche.pdf