ShockPulse Lithotripsy System, Generator and Transducer
Brand(s)
Last updated
Summary
Product
ShockPulse Lithotripsy System, Generator and Transducer
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 | All lots. | SPL-S |
| ShockPulse Lithotripsy Generator | All lots. | SPL-G |
| ShockPulse Lithotripsy Transducer | All lots. | SPL-T |
Issue
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.
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-81442
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