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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00236-1
Product Name/Description ML 301 Examination Lamp
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/03/2013
Responsible Entity Medsell Sales Pty Ltd T/A Denyers International
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.
Recall Action Recall for Product Correction
Recall Action Instructions Denyers International inspected all units to determine which units required the correction. All units were identified as not affected by the issue.
Contact Information 02 9627 3299 - Denyers