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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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.
The device generator may remain in a blinking phase and fail to recognize the transducer. Damage to the transducer plug or generator receptacle may cause malfunctions during use.
1. Stop using the device immediately. 2. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. 3. Follow the recall letter instructions for any required action, repair, or service. 4. Maintain documentation of all communications.
Remedy coordination and official guidance come through the manufacturer. Specific phone, website, and hours are not provided in the data. Follow the FDA recall page for official details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1479-2026
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