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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 066 06 18 000
Date submitted: 6/17/2018
Manufacturer:GE Healthcare
Device Type:Discovery MR750w
Description:MRI
Medical Device Identifier:All
Reason of Field Safety Corrective Action:A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.
Remedy Action:You can continue to use the system by following the existing Operator Manual Safety Information for proper patient padding and observation during scanning. This safety information includes:

• WARNING: Place appropriate non-conductive padding between the patient and the bore wherever a portion of the body may come into contact with the magnet opening.

• CAUTION: Continuous patient observation and contact are required in all modes of operation.

• CAUTION: Extra attention should be utilized when scanning patients who are unconscious, sedated, or may have loss of feeling in any body part or are physically or mentally impaired and unable to alert the personnel.

GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:3110BA9F88222
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf