| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00972-1 |
| Product Name/Description |
G-scan Brio Magnetic Resonance System
Part Number: 101002000
Serial Numbers: 5317, 5318
ARTG Number: 216657 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
02 9006 1662 - Emergo Australia |