Olympus Corporation of the Americas is recalling 1,082 ShockPulse Lithotripsy System SPL-S single-use probes worldwide. Investigations found the device’s generator may blink and fail to recognize the transducer, risking damage to the transducer plug or generator receptacle. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
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 Lithotripsy System is used to fragment kidney stones and aspirate debris. The transducer is reusable and requires cleaning and steam sterilization before use.
A blinking generator that fails to recognize the transducer can indicate internal electrical or receptacle issues. Damaged plugs or receptacles may lead to device malfunction during procedures.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics may need to halt procedures using this device and turn to safe alternatives. The recall could affect procurement and operational workflow for lithotripsy services.
UDI on packaging and labeling; model number printed on device; recall letter from Olympus
Typically 4-6 weeks for refunds or replacements after approval
Retain recall letter, save all email/phone communications, log device serials and UDI, keep purchase records and replacement confirmations
Model/Catalog Number: SPL-S. UDI: 00821925044197. Serial Numbers: All. Distribution: Worldwide, including US, Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Sold at: Unknown. Sold since: Unknown. Price: Unknown. Quantity: 1082 units. Country of origin: Unknown. Classification: Class II.
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