Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System -
- Recall date
- 2026-03-11
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
1082 units
Product description
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.