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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 039 03 12 000
Date submitted: 3/11/2012
Manufacturer:Etac Supply Center AB
Device Type:Basic walker, non-foldable, Walker Avant, Avant LW, Salsa
Description:Walker, non-foldable
Medical Device Identifier:Walker Avant, Avant LW, Salsa
Reason of Field Safety Corrective Action: Wheels may come off causing a risk of injury When delivered from Etac the wheels are mounted on each axle and fastened with a spring-loaded ring, called a lock ring. The lock ring is placed in a groove in the axle, thereby preventing the wheels coming off. When assembling or changing the wheels it is possible to open the lock ring too much, which causes a loss of its springing quality, and can then not be fastened properly. Another error may occur if the lock ring is mounted without ensuring that it fits into the groove all the way around the axle. Both of these assembling errors may give the impression that the wheels are properly fastened, but such wheel can come off if it gets struck or hits an obstacle that affects the wheel sideways.
Remedy Action:Etac wants to reach the customers (distributor) and users to give information on how to check the wheels. This is made by Two Field Safety Notices (FSN), one for users and the other for customers. Customers were requested to check the wheels on the Walkers Avant, Avant LW and Salsa when performing service or reconditioning, as described in the FSN, and note the serial number of the product. The number of checked walkers and found errors shall be reported with serial numbers to Etac by agreed schedule. Users were requested to turn to assigned place as described in the user-FSN and, if relevant for the market, separate invitation for inspection of the Walkers Avant, Avant LW and Salsa.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:SE-2012-03-06-007
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments