| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00567-1 |
| Product Name/Description |
Abbott Medical Optics (AMO) STAR Excimer Laser System
Models: S3, S4 and S4 IR |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential for an inadvertent laser firing with no surgeon interaction on the foot pedal due to incorrect output of electrical foot switch buffer when the following conditions are present:
1- circuit breaker C9 is tripped open, causing a Remote Panel PCB power loss
2- normal system interlocks are cleared (system waiting for surgeon intervention)
There have been no reports of inadvertent firing of the laser in the field. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott Medical Optics is replacing the circuit board component of all STAR Excimer Laser Systems. The manufacturer has advised that the devices may continue to be used to treat patients. In the unlikely event that the system initiates treatment without direct input, physicians are advised to immediately use the Laser Stop Button located on the doctor's panel as described in the Operators Manual. |
| Contact Information |
1800 266 111 - Abbott Medical Optics Australia |