Olympus Corp. of the Americas recalls 55 ShockPulse-SE Lithotripsy System units distributed internationally. Mis-wired component may create noise on the power supply and ultrasonic circuit. Hospitals and providers should stop using the device immediately and follow recall instructions. Notify Olympus or your healthcare provider for guidance.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The ShockPulse-SE Lithotripsy System fragments urinary tract stones using pneumatic shock waves and ultrasonic energy. It typically includes a control unit, handpieces, and two probe types.
A mis-wired component can cause noise on the power supply and ultrasonic input circuit, potentially decreasing system reliability and delaying treatment.
This recall is not described as part of a broader industry pattern.
Hospitals may need to suspend use of affected equipment and implement alternative stone-treatment methods while the recall is addressed.
Look on device labels, the UDI plate, and hospital-maintained equipment records
Remediation timelines vary; expect weeks to months for replacement or repair processes
Keep the recall notification, serial numbers, UDI labels, correspondence with Olympus, and any incident reports for records
Model/Catalog Numbers: SPL-SR; SPL-G (generator). UDI: SPL-SR 00821925043824; SPL-G 00821925044203. Serial Numbers: CG5026–CG5042. Quantity: 55 units. Sold internationally in Canada, Germany, Singapore, Australia, and India. Recall date: 2026-01-08. Status: ACTIVE. Brand: Olympus. Category: Medical devices distributed through international channels.
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