| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00168-1 |
| Product Name/Description |
Olympus Soltive Premium SuperPulsed Laser System
Product Code: TFL-PLS
ARTG 344431
(Olympus Australia Pty Ltd - SOLTIVE Superpulsed Laser System (Laser Consoles, Fibers, Footswitches) - Surgical Ho:YAG laser system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Olympus found that if the power cord used for the Soltive Laser device is non-compliant it may affect the performance of the device. Potential harms that may be associated with the use of a non-compatible power cord include burns or electrical shock to the user, or prolonged surgeries/cancellation of procedures.
Globally, Olympus has received a total of five (5) complaints where the use of a power cord could have potentially contributed to the event. These include an event classified as serious injury where the procedure was cancelled and a report of malfunction. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
To address this situation, customers are to confirm the installed power cord meets the specifications, or quarantine their Soltive Laser System and schedule an immediate on-site inspection to inspect and replace any non-compliant power cords. |
| Contact Information |
1300 132 992 - Olympus Customer Operations |