Olympus Corporation of the Americas is recalling 1,684 ShockPulse-SE Lithotripsy System generators worldwide, including SPL-G models. Investigations found the generator can blink and fail to recognize the transducer, and damage to the transducer plug or generator receptacle may occur. Healthcare providers and patients should stop using the device immediately and follow recall instructions provided
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 stones and aspirates debris. The transducer is reusable and requires cleaning and steam sterilization.
A blinking generator may fail to recognize the transducer, potentially causing malfunctions due to damage to the transducer plug or generator receptacle.
This recall is not indicated as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to halt procedures using SPL-G generators until recall instructions are followed. The recall impacts equipment used in stone fragmentation procedures.
FDA recall page and manufacturer communications; official recall letter from Olympus
Not specified in the provided data; follow the recall letter for instructions and potential repair/replacement timelines
Keep the recall letter, note the device model, UDI, serial numbers, and all communications with Olympus or clinicians; photograph any device issues
Model/Catalog Number: SPL-G. UDI: 00821925044203. Serial Numbers: All. Distribution: Worldwide, including US nationwide and Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. When sold: Unknown. Price: Unknown.
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