Recall Monitor
Health Products

ShockPulse Lithotripsy System, Generator and Transducer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: ShockPulse Lithotripsy System, Generator and Transducer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Model or catalogue numberLot or serial numberAffected products
SPL-TAll lots.ShockPulse Lithotripsy Transducer
SPL-GAll lots.ShockPulse Lithotripsy Generator
SPL-SAll lots.ShockPulse-Se Lithotripsy System

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.

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