Discovery MR450, MR750 and Optima MR450w MRI System 의 리콜

Recall

RC-2013-RN-00885-1

Class II

2013-08-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00885-1

Ge healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of discovery mr450, mr750 and optima mr450w product. the yellow foam strip used between the end bell covers and patient bore of certain ge mr products may extend past the surface of the covers. the foam itself is not hazardous. however, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another.

GE Healthcare is advising users that the system may continue to be used as normal even with the yellow foam protruding from the bore. Patient padding should be used as described in the Operating manuals and cleaning practices described in the Operating manuals should be followed. Patient padding will minimise contact with the foam and users are advised not to attempt to remove the foam. GE Healthcare will be installing a permanent cover over the foam in October 2013.