Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reu

FDA device recall Z-1494-2026 · posted 2026-03-05 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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.

Action taken

On January 8, 2026, URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any affected devices. 2. Contact your Olympus Customer Service contact to obtain a Return Material Authorization and arrange for the return of your device. Olympus will repair the affected part at no charge and return the device back to you. 3. If you have further distributed the affected products, please forward this notification to other users who may have them. Olympus requests you to report any complaints related to the ShockPulse device to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Root cause

Device Design

Status

Open, Classified

Product code

FEO

Quantity affected

55 units (All OUS)

Distribution

International distribution in the country of Canada, Germany, Singapore, Australia, and India.

Date initiated

2026-01-08

Date posted

2026-03-05

Location

Center Valley, PA

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