CanadaGyrus Acmi’s ShockPulse Lithotripsy System, Generator and Transducer (models SPL-S, SPL-G, SPL-T; all lots/serial numbers) are affected. Olympus identified instances of the ShockPulse generator remaining in a blinking phase waiting to recognize the transducer, which can impact transducer functionality; a back-up transducer and probe should be sterilized and available prior to procedure. Contact the manufacturer for additional information.
What's being recalled
Companies: Gyrus Acmi, Inc, 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445.
How to identify it
Affected products: ShockPulse-Se Lithotripsy System; Lot or serial number: All lots.; Model or catalogue number: SPL-S
Affected products: ShockPulse Lithotripsy Generator; Lot or serial number: All lots.; Model or catalogue number: SPL-G
Affected products: ShockPulse Lithotripsy Transducer; Lot or serial number: All lots.; Model or catalogue number: SPL-T
The hazard
Olympus has identified instances of ShockPulse generator remaining in a blinking phase waiting to recognize the transducer following previous FY26-010 recall. Due to the potential for these issues to impact the functionality of the ShockPulse transducer, it is important a back-up transducer and probe are sterilized and available prior to procedure.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)