| TGA Action ID |
RC-2025-RN-01096-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ShockPulse-SE Lithotripsy System – Reusable Probes and ShockPulse Lithotripsy Generator
Model Numbers: SPL-SR & SPL-G
Serial Number: CG5047 |
| ARTG Number |
343651 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Specific serial numbers of ShockPulse generators may have a mis-wired component. This condition does not impact the intended functionality of the device; however, the miswiring may introduce additional electrical noise on the power supply output. The presence of noise on the ultrasonic input circuit is not compliant with applicable electromagnetic compatibility (EMC) standards and may adversely affect the overall reliability of the system.
In the unlikely event that the ShockPulse Lithotripsy generator’s output becomes reduced, inconsistent, or ceases entirely, there is a potential for procedural delays while troubleshooting or replacing the generator. If a replacement unit is not immediately available, the procedure may need to be cancelled and rescheduled.
OIympus has not received any complaints or reports of serious injury associated with this matter. |
| Instructions for Customers/Users |
Following receipt of a completed Response form (supplied to customers by Olympus), Olympus will arrange the return and repair of the affected device at their Repair Centre, after which the device will be returned to the customer.
This action has been closed out on 16/07/2026 |
| Action Commencement Date |
2/01/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |