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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 078 09 15 000
Date submitted: 9/15/2015
Manufacturer:Eurovema AB
Device Type:Miniflex, Flexmobil, Forma
Description:wheelchairs and work chairs
Medical Device Identifier:See enclosed list in attached file
Reason of Field Safety Corrective Action:The affected products are work chairs and electrical wheelchairs from Eurovema AB. A manufacturing error has caused breaks in the actuator bracket in the seat cross.
Remedy Action:The actuator bracket will be replaced. Users with listed serial number of a chair will be contacted by distributor or Eurovema for information about where and when the replacement will take place.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:SE-2015-09-08-022
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: SE-2015-09-08-022_FSN_090915 with listed products.pdf