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Olympus Corporation of the Americas recalls OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Recalled June 10, 2020 · FDA recall Z-2197-2020 · Olympus Corporation of the Americas
Hazard
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. · FDA Class II
Units
18
Sold at
Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Description
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Product
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →