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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 073 01 16 000
Date submitted:
1/19/2016
Manufacturer:
IBA Dosimetry GmbH
Device Type:
Electrical lift table
Description:
lift table
Medical Device Identifier:
Part No.: HA03-000#002, HA03-010#002
Reason of Field Safety Corrective Action:
When the Electrical Lift Table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. To prevent this error from occurring, please follow the instruction in the section below until this problem is completely resolved.
Remedy Action:
Before receiving the replacement part: Disconnect the mains power connection of the Electrical Lift Table after setting up the table and BP2. The Table must not be connected to the mains power when its electrical functions are not in use for alignment. After receiving the replacement part: A new Hand Control including its cable will be sent to you when it is ready. The replacement instruction will be included in the shipment. Af-ter you receive the shipment, immediately replace the original one.
Athorized Representative/Importer/Distributor:
Al-Faisaliah Medical System
Report Source:
NCMDR
Source Ref. Number:
2FCF499C65248
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
IBA.pdf
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