Olympus Corporation of the Americas recalls OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
- Recall date
- April 23, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2197-2020
- FDA classification
- Class II
- Brand / firm
- Olympus Corporation of the Americas
- Sold / distributed
- Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Why it was recalled
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
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