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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 063 06 12 000
Date submitted: 6/12/2012
Manufacturer:Arcomed AG
Device Type:Pumps, Syramed SP6000, Volumed VP7000
Description:Syringe pump; Infusion pump
Medical Device Identifier:Syramed SP6000 + Volumed VP7000 Volumed ~VP7000 Premium, Volumed ~VP7000 Classic Plus Volumed ~VP7000 Lite Syramed ~SP6000 Premium Syramed ~SP6000 Classic Plus
Reason of Field Safety Corrective Action:The ribbon cable, which connects the display PCB with the main PCB of the pumps, may show aging effects after a certain time. This aging effect reveals mainly in stiffening of the isolation of the ribbon cable where the ribbon cable is in contact with the hinge.
Remedy Action:Arcomed ag recommends during the periodical maintenance of the pump to check the ribbon cable according to attached file and if necessary to change the ribbon cable.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:CH-2012-06-07-029
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Arcomed AG.pdf