Z-1477-2026 Class II Ongoing
FDA device recall Z-1477-2026 was initiated by Olympus Corporation of the Americas on November 14, 2025 and is designated Class II. 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 recepta… The recall status is ongoing. Affected quantity: 602 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2026
- Initiation Date
- November 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 602 units
Product Description
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR 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.
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Code Information
Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;