FDA recall Z-2197-2020

Olympus Corporation of the Americas · Class II · device

Product

OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer

Reason for recall

A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

Distribution

Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.

Key facts

Status: Terminated
Initiation date: 2020-04-23
Report date: 2020-06-10
Termination date: 2024-10-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2197-2020