Olympus ShockPulse-SE Lithotripsy System Generator
Olympus is recalling the ShockPulse-SE Lithotripsy System generator due to a mis-wired component that may cause treatment delays.
Contact your Olympus representative or the company's technical support department to arrange for the inspection and correction of the affected generator units.
Why it was recalled
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
How to identify it
UPC 00821925043824 00821925044203
Official source
Other recent recalls from Olympus Corporation of the Americas
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification