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.
This action was undertaken without consulting the TGA. |