| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00204-1 |
| Product Name/Description |
MAGNETOM Biograph mMR
Product code: 10433372
ARTG 274035
(Siemens Healthcare Pty Ltd - PET/MRI system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
When certain parameters (echo spacings 0.50 ms; 0.51 ms, and 0.52 ms) are used in EPI (echo-planar imaging), sequences will excite high internal stress inside the gradient coil assembly. This may lead to cracks in the gradient coil.
These cracks may lead to damage of the gradient coil (water leaks, cable breaks, etc). In rare cases, such a crack may cause a break in the internal wiring of the gradient coil. This can lead to arcing and ultimately to smoke emission. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to not use echo spacings of 0.50 ms, 0.51 ms, or 0.52 ms in epi sequences and are to carefully check the echo spacing of the sequences before starting them, further information is provided in the customer letter (supplied by the sponsor to affected customers).
To correct the issue a software solution is being developed and is planned to be available by the end of quarter 3 in 2024. Based on their investigation, Siemens is advising the system can continue to be used if the above parameter settings are avoided. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |