Retiro De Equipo (Recall) de Discovery MR450w, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w and Discovery MR750w equipped with the GEM option products (Full body magnetic resonance imaging (MRI) systems)

Recall

RC-2014-RN-00464-2

Class I

2014-04-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00464-2

Ge healthcare has recently become aware of a potential safety issue with the patient table cradle emergency release handle and cradle release block mechanism of certain ge mri products. patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. this could make difficult the safe removal of the patient from the system.

GE Healthcare will correct all affected products. Before continued use prior to repair, GE is advising that the operator should assess patient positioning and ease of egress and cease use if cradle movement for egress is impeded. If the operator encounters difficulty in moving the cradle out because the cradle release handle does not release properly or if the cradle movement is impeded, the facility’s GE Healthcare Service Representative should be contacted so that the cradle can be inspected and necessary repairs can be made as soon as possible. This action has been closed-out on 02/02/2016.