| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00499-1 |
| 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 |
26/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer is providing users with additional safety instructions for the safe use of the Magnetic Resonance System G-scan Brio. If not addressed, the issue described 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 that part of the table to access or descend from the bed. There is a chance of a patient falling, or patient injury to the head or back if this situation occurs. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is providing users with work around instructions to follow to prevent the issue from occurring. The Instructions for Use (IFU) will be updated to include the additional information. This action has been closed-out on 13/10/2016. |
| Contact Information |
02 9006 1662 – Emergo Australia |