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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 072 07 12 000
Date submitted: 7/18/2012
Manufacturer:V.Guldmann A/S
Device Type:GH3 Lifting Hanger
Description:Lifting hanger
Medical Device Identifier:Model 550316(medium), 550057(small), 550058(x-small)
Reason of Field Safety Corrective Action: Lifting straps have not been correctly placed and patients have fallen partially or completely out of the sling.
Remedy Action: In order to carry out a safe lift or transfer of a patient it is a condition that the person who operates the product checks that the lifting straps from the sling are correctly placed in the lifting hanger’s hooks and that the patient is correctly placed on the sling, especially before starting to lift the patient. The new instruction is attached to this FSN, and the new User Manual will automatically be sent to all customers in August 2012. The number of User Manuals will correspond to the number of lifting hangers purchased.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:DK-2012-07-12 - 015
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: V.Guldmann A-S.pdf