| TGA Action ID |
RC-2026-RN-00723-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LithoVue Elite StoneSmart Connect Console Power Adaptor
Batch: Rev A-C
Part number: TR9CE13330KP4FRIMR6B |
| ARTG Number |
393372 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Boston Scientific has identified that specific lots of the LithoVue Elite StoneSmart Connect Console were supplied with power adaptors that may not meet protective earth resistance testing requirements. As a result, the power adaptor may fail electrical safety testing during installation. This condition is readily detectable when electrical safety testing is performed during installation.
Internal testing has demonstrated that the adaptor continues to provide isolated low-voltage power and does not present an electrical shock hazard to users or patients. There is no impact to the safety or performance of the Console.
No reports of patient harm have been received relating to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Continue to use the affected devices according to the Instructions for Use.
- Complete and return the Customer Acknowledgement Form.
- Begin using the replacement power adaptor upon receipt and dispose of the affected power adaptor in accordance with local requirements. |
| Action Commencement Date |
21/09/2026 |
| Responsible Entity |
|
| Contact Information |
anz_incident_report@bsci.com - Boston Scientific |