Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE ...
Reason for Recall / Hazard
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Product Description & Identification
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Affected Products
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98359 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All; |
| Postal code | 18034-8229 |
| Report date | 20260311 |
| Product type | Devices |
| Product quantity | 1082 units |
| Reason for recall | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251114 |
| Initial firm notification | Letter |
| Center classification date | 20260227 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.