Shockpulse Lithotripsy System, Generator And Transducer

The ShockPulse Lithotripsy System, which includes a generator and transducer used to break up kidney stones, is being recalled in Canada due to performance issues. This Class I recall affects units distributed across Canada. The system may not function as intended during medical procedures.

Product
ShockPulse Lithotripsy System, Generator and Transducer
Reason
Performance
Classification
Class II
Category
medical device recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-12-31
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c5d465ba-b225-4fff-a5b5-625b5af0e6bb