Reported Jun 10, 2020 · Terminated
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
- Lot codes and dates
- Serial numbers
1910PW306077051910PW306077121910PW306076011910PW306077081910PW306077091910PW306077011910PW306078141910PW306079061910PW306076031910PW306077061910PW306078021910PW306078081910PW306078091910PW306078041910PW306077131910PW30607803
- Lot Numbers
CG2003CG2010CG2011CG2026CG2027CG2033CG2035CG2000CG2025CG2001CG2019CG2022CG2029CG2021CG2008CG2036CG2037CG2006CG2004CG2007CG2012CG2013CG2015
- Serial numbers
- Amount recalled
- 18
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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