| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01219-1 |
| Product Name/Description |
Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)
Manufactured between 15 May 2009 and 15 July 2009.
ARTG Number: 199091 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified these products as possibly having a faulty coupling spacer. The coupling spacer used during this period was made out of plastic and in some instances the plastic spacer can break. When the coupling spacer is damaged, the column shaft will make a noisy sound when the operator continues to adjust the Up/Down switch.
This recall action was not notified to the TGA before it was initiated by Vatech Medical. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is providing users with work around instructions and will be replacing the spacers on all affected devices.
This action has been closed out on 09/01/2019 |
| Contact Information |
02 9644 4866 - Vatech Medical |