Recall MonitorHealth Products
ShockPulse-Se Lithotripsy System and ShockPulse Lithotripsy Generator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
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
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| ShockPulse-SE Lithotripsy System | All lots. | SPL-S |
| ShockPulse Lithotripsy Generator | All lots. | 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.