Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S Recalled by Olympus Corporation of the Americas Due to Mis-wired component-the improperly wired component can result in...

Date: July 7, 2022
Company: Olympus Corporation of the Americas
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.

Affected Products

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Quantity: 2 units

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Olympus Corporation of the Americas

Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report