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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 014 09 16 000
Date submitted: 9/20/2016
Manufacturer:Welch Allyn Protocol Inc
Device Type:MS3 Connex Spot Classic Mobile Stand & Power Supply
Medical Device Identifier:All
Reason of Field Safety Corrective Action:It has been brought to the attention of Welch Allyn via customer complaints in the UK that under certain circumstances the power supply casing at the weld joint (housing) can separate which, as a result, exposes electrical components.
Remedy Action:Please continue to ensure that users of these devices take the following precautions:

-As per your Instructions For Use, routinely check your devices for physical damage to the power cords & transformers.

-Do not use damaged power cords and transformers, and report such damage to Welch Allyn and request replacements as necessary.

-Always ensure your device is unplugged from the wall before you move the stand.

-If you identify exposed wires on your power cords/transformers, do NOT make physical contact with it. Switch off the plug at the wall and contact your Biomedical/Clinical Engineering department.

The device PSU has met all of its required testing (e.g. drop test) for electrical certification. Working with its PSU supplier, Welch Allyn has introduced further improvements to the PSU ultrasonic welding process. In the interim, Welch Allyn have also designed a Power Supply Bracket Kit (PN 411626) to retrofit to the mobile stand to further prevent the power supply from splitting apart.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:BCF966E204301
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Welch Allyn.pdf