CanadaGyrus Acmi’s ShockPulse‑SE Lithotripsy System (model SPL‑S) and ShockPulse Lithotripsy Generator (model SPL‑G) with serial numbers CG6086 and CG7004 are affected. Olympus found through an internal investigation that specific serial numbers of ShockPulse generators may have a mis‑wired component. Users should contact the manufacturer or customer service to arrange return of the device for repair or 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: CG6086; Model or catalogue number: SPL-S
Affected products: ShockPulse Lithotripsy Generator; Lot or serial number: CG6086; Model or catalogue number: SPL-G
Affected products: ShockPulse-SE Lithotripsy System; Lot or serial number: CG7004; Model or catalogue number: SPL-S
Affected products: ShockPulse Lithotripsy Generator; Lot or serial number: CG7004; Model or catalogue number: SPL-G
The hazard
Olympus discovered through an internal investigation that specific serial numbers of ShockPulse generators may have a mis-wired component. Users should contact customer service to arrange the return of their device for repair.
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)