G-scan Brio Magnetic Resonance System 의 리콜

Recall

RC-2016-RN-00972-1

Class II

2016-07-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00972-1

Emergo is providing additional safety instructions for the safe use of the magnetic resonance system g-scan brio. the issues could lead to an unsafe exam condition.A potential weakness in the foot rest and the left bed rail of the patient table has been identified. this weakness may lead to a fracture of the patient table within the foot rest and the left bed rail in certain conditions. in particular this may happen if a heavy patient applies a strong dynamic stress (bouncing stress) to these specified areas of the table to access or descend to/from the table. there is a chance of a patient falling, or patient injury to the head or back if this situation occurs.Additionally, there is a potential weakness in the patient seat used for some specific weight-bearing examinations such as shoulder, cervical spine and temporo-mandibular joint, with patients weighing near or in excess of the defined limits. this weakness in the patient seat may lead to a fracture within the seat.

Emergo is advising users that for non-weight bearing exams, to ensure patients access and descend from the patient table in the defined area. For weight bearing exams, patients must access and descend from the table in a vertical position. Further, the weight limit for weight bearing exams has been reduced to 110kg. Patients weighing over this limit must be examined in a horizontal position. Emergo will be providing updated labelling and IFU to all affected customers. Investigations into a permanent correction are being undertaken by the manufacturer. This action has been closed out on 15 June 2017.