| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01114-1 |
| Product Name/Description |
A-dec 200 Dental Chair (examination chair)
All batches/serial numbers manufactured since March 2011
ARTG Number: 118326 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Preliminary analysis indicates that several lots of mounting bolts were subjected to plating conditions that may have contributed to hydrogen embrittlement, which in turn could cause mounting bolt failure. It was also determined that in addition to mounting bolts for the support centre that mounting bolts for the upper structure attachment to the chair base could also have been subjected to plating conditions that may have contributed to hydrogen embrittlement.
This recall action was not notified to the TGA before it was initiated by A-Dec Australia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users that the dealer will be replacing the four support centre bolts. |
| Contact Information |
02 8332 4000 - A-dec |