FDA-Device2020-06-10Class II
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
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.
Sold states
Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
Affected count
18
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2197-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief