| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01014-1 |
| Product Name/Description |
Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)
Part Number: 9784-00
Serial Numbers: 2687, 2676
ARTG Number: 136823 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Magstim has identified a manufacturing non-conformity on a single 9784-00, Magstim 90mm High Power Coil. The nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. Although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. The failure mode would be such that a loud bang would be produced and the coil would cease to function. There could also be damage to the stimulator to which the coil was connected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtel is requesting users to stop using the coils. Product can be returned to Medtel for replacement with unaffected stock. |
| Contact Information |
1300 886 385 - Medtel Australia Customer Support |