Product Safety Recalls

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Olympus Corporation of the Americas Recall 90585

Description: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Olympus Corporation of the Americas Recall 90585 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1514-2022
Event ID90585
Event DescriptionShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, NM.
Quantity2 units
Recall ReasonMis-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 treatment
Device Classification20220817
Device Code InfoUDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
Center Classification Date20220811
Recall Initiation Date20220707
Recalling FirmOlympus Corporation of the Americas
Initial Notification Letter
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