| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01230-1 |
| Product Name/Description |
Siroclave Dental Sterilisers (moist heat autoclave)
ARTG Number: 197032 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
The locking bolt of the door latch can bend or even break under unfavourable conditions.
This recall action was not notified to the TGA before it was initiated by Sirona Dental Systems. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to follow work around instructions and will replace the door mechanism of all Siroclaves installed in Australia. |
| Contact Information |
02 9496 5100 - Sirona |