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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01150-1
Product Name/Description Slit Lamp

Model Number: SL 220

Serial Numbers: 970712XXXX and 970714XXXX

ARTG Number: 94353
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 4/09/2017
Responsible Entity Carl Zeiss Pty Ltd
Reason/Issue Based on post market surveillance activities, Carl Zeiss has determined that in certain devices there is an increased probability of failure of the power supply ON/OFF switch, and surface corrosion of the mirror which changes the direction of the light projection.

There is no potential health hazard and the probability of injury is extremely unlikely. In a worst case scenario, a burning smell may result from a thermal event at the power supply ON/OFF switch. Issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. The slit projection may be slightly darker and more diffused.
Recall Action Recall for Product Correction
Recall Action Instructions Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.

This action has been closed out on 18/09/2018
Contact Information 1300 367 244 - Carl Zeiss