ShockPulse-Se Lithotripsy System and ShockPulse Lithotripsy Generator
Brand(s)
Last updated
Summary
Product
ShockPulse-Se Lithotripsy System and ShockPulse Lithotripsy Generator
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ShockPulse-SE Lithotripsy System | CG6086 | SPL-S |
| ShockPulse Lithotripsy Generator | CG6086 | SPL-G |
| ShockPulse-SE Lithotripsy System | CG7004 | SPL-S |
| ShockPulse Lithotripsy Generator | CG7004 | SPL-G |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81508
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