Olympus Corporation of the Americas
Device Recalls (Class II)
Class II
Z-1494-2026
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20260311
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Ongoing
Product
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Produ...
Reason for Recall
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of tr...
Distribution
International distribution in the country of Canada, Germany, Singapore, Australia, and India.
Source: openFDA Enforcement API