Olympus ShockPulse-SE Lithotripsy System recalled for generator recognition failure
Contact Olympus about ShockPulse-SE device issues
The Olympus ShockPulse-SE Lithotripsy System, used to break up kidney stones and similar calculi, may experience problems where the generator remains in a blinking phase and fails to recognize the transducer. This can happen if the transducer plug or generator receptacle becomes damaged. No injuries have been reported.
- If you use this device in a clinical setting, contact Olympus Corporation of the Americas for guidance on your specific unit
- Do not use the device if the generator blinks and does not recognize the transducer
- Check the transducer plug and generator receptacle for any visible damage
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2026More Olympus Corporation of the Americas recalls
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