FDA-Device2026-03-11Class IIPROCESSING DEFECT

Olympus ShockPulse-SE Lithotripsy System recalled for wiring defect affecting device reliability

OTHERNationwide distribution

Contact Olympus about ShockPulse-SE Lithotripsy System

Olympus has identified a mis-wired component in certain ShockPulse-SE Lithotripsy System generators (model SPL-G) that can cause electrical noise in the ultrasonic circuit. This noise may reduce the system's reliability and delay treatment. The recall affects 55 units distributed internationally.

If your facility operates a ShockPulse-SE system, check if your generator serial number matches the list (CG5026–CG7003)
Contact Olympus Corporation of the Americas immediately for instructions
Do not operate affected units until you receive guidance from Olympus

Hazard

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.

Sold states

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

Affected count

55 units (All OUS)

Manufactured in

3500 Corporate Pkwy, N/A, Center Valley, PA, United States

Products

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2026

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