medical Class II Updated 2022-08-17

Olympus Corporation of the Americas recalls ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Recalled Product

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

Hazard / Issue

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 treatment

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00821925044197 Serial numbers: CG5085 and CG6009
View official government recall

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