CanadaShockPulse Lithotripsy Transducer (Gyrus ACMI, model/catalogue number SPL‑T; affected lot/serial numbers: more than 10 numbers — contact manufacturer) is affected. Olympus found the SPL‑T may fail to start and the transducer handpiece body may gradually increase in temperature during use, potentially before its expected lifespan, and users are advised to have a backup transducer and sterilized probe ready prior to beginning a 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 Lithotripsy Transducer; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SPL-T
The hazard
Olympus found that the SPL-T transducer may fail to start. In addition, the body of the transducer handpiece may gradually increase in temperature during use, potentially before its expected lifespan. users are advised to have a backup transducer and sterilized probe ready prior to beginning a 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)