The FDA has posted 5 enforcement recalls of ultrasonic lithotriptor devices since 2025, none of them Class I (most serious). Most recent report: Mar 11, 2026.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Lithotriptor, Ultrasonic”). Informational only — verify against the FDA before acting.