X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 065 10 11 000
Date submitted: 10/23/2011
Manufacturer:Arjo Hospital Equipment AB
Device Type:Bath, whole body, walk-in
Description:Bath, whole body
Medical Device Identifier:Parker 500 AL2xxxx-xx Serial No: All (159 units worldwide)
Reason of Field Safety Corrective Action:An incorrect routing of a mains supply cable may allow for the supply cable to be cut by the high/low actuator yoke. A cut mains supply cable may cause an electrified framework leading to the risk of serious injury or death.
Remedy Action:All units will be rebuilt preventing re-occurrence, assembly instructions have been updated and implemented. All use must stop immediately and the tub/bath must be disconnected from the mains electrical supply. The following will be communicated to the end user via local sales and service units. Tub must be quarantined pending correction. The correction involves re-routing or replacement of the mains supply cable.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119999
Report Source:NCAR
Source Ref. Number:SE-2011-10-17-040
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Code Information- Arjo Hospital.pdf