| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00080-1 |
| Product Name/Description |
All GE Healthcare MRI systems with superconducting magnets
ARTG 223115
(GE Healthcare Australia Pty Ltd - MRI system, full-body, superconducting magnet) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/01/2022 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare is advising that the GEHC Magnetic Resonance (“MR”) systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet quench, potentially depriving the room of oxygen.
In the rare event a magnet quenches, it is easily detectable by the presence of a loud noise, warning messages, or the tilting of an image on the display screen.
There have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare is advising customers that they can continue to use the system as normal. Customers are asked to follow the instructions in the customer letter (supplied to affected customers) to ensure the system is inspected (either by GE Healthcare or the organisation who installed the ventilation system) and confirm it complies with the safety requirements for ventilation and was installed per the GE Healthcare specifications in the Pre-Installation Manual. |
| Contact Information |
1800 659 465 - GE Healthcare Service |