| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00217-1 |
| Product Name/Description |
ML 301 Examination Lamp
ARTG: 96992 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
There are reports that after an average usage period of seven years fatigue failure of the plastic joint may occur. The manufacturer has become aware that a joint on the spring arm may break either during use or when the spring arm is not in operation. If the joint breaks, the spring arm falls suddenly and without hindrance. In such a case there is a high risk of injury to the patient and other persons in the immediate vicinity. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to inspect all units to determine if the swing arm has a plastic joint. If the joint is plastic the spring arm must not be used. A replacement spring arm will be provided for all affected units. |
| Contact Information |
1800 225 065 - Medical & Optical Instruments Australia Pty Ltd |