Olympus Corporation of the Americas has recalled 1,528 ShockPulse Lithotripsy Transducers (Model SPL-T). These reusable surgical devices may fail to start, stop unexpectedly during use, or experience a gradual increase in the temperature of the handpiece during clinical procedures. If the device fails or stops during a procedure, it can cause surgical delays and prolonged anesthesia, while overheating poses a risk of thermal injury to users or patients. Consumers should stop using the affected transducers and contact the manufacturer to arrange for a return or correction.
The transducer handpiece can gradually overheat during use, potentially causing burns to medical staff or patients. Additionally, the device may fail to start or shut down during a procedure, requiring surgical interruption or leading to patient complications from extended anesthesia.
The ShockPulse Lithotripsy System is an electromechanical device used to fragment and aspirate calculi and stone debris.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.