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Olympus Corporation of the Americas recalls ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Recalled August 17, 2022 · FDA recall Z-1514-2022 · 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 · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the states of AL, NM.
Description
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
Product
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →