Olympus Corporation of the Americas recalls 602 ShockPulse-SE Lithotripsy System reusable probes worldwide to hospitals. The recall cites a blinking generator that may fail to recognize the transducer and damage the transducer plug or generator receptacle. Hospitals and patients should stop using SPL-SR probes immediately and follow manufacturer recall instructions.
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 fragments urinary stones using low-frequency mechanical energy and high-frequency ultrasonic energy. Reusable probes require cleaning and steam sterilization between procedures.
A blinking generator that does not recognize the transducer can lead to device malfunction. Damage to the transducer plug or generator receptacle increases the risk of improper operation during procedures.
This recall is not part of a broader industry pattern.
Hospitals may need to halt certain lithotripsy procedures. The recall focuses on device reliability and patient safety. No injuries are reported in the notice at this time, but the risk is significant for procedural success.
Identifiers are on device labels, packaging, and user manuals. UDI is also in the FDA recall listing.
Replacement or remediation steps are coordinated with Olympus and hospitals within weeks. Expect official timelines from your facility.
Keep copies of the recall notice, correspondence with Olympus, purchase invoices, and device identifiers for future reference.
Model/Catalog Number: SPL-SR. UDI: 00821925043824. Serial numbers: All. Distribution: Worldwide, including the US, Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Sold: Unknown. Date sold: Unknown. Price: Unknown.
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