FDA-Device2022-08-17Class II
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Olympus Corporation of the Americas
Hazard
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
Sold states
US Nationwide distribution in the states of AL, NM.
Affected count
2 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2022Don't want to check this manually?
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