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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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.
A mis-wired component can generate additional noise on the power supply output. Noise on the ultrasonic input circuit may not meet EMC standards. The issue can reduce system reliability and delay treatment.
1. Stop using the device immediately. 2. Follow the manufacturer recall instructions. 3. Contact Olympus Corporation of the Americas or your healthcare provider for guidance. 4. Monitor hospital device records and report any issues per institutional protocol.
Notification by letter. For recall assistance, contact Olympus Corporation of the Americas via their official recall channels. Hours of operation are not specified in the provided notice.
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