FDA-Device2025-01-22Class II
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Olympus Corporation of the Americas
Hazard
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Sold states
US Nationwide distribution.
Affected count
989 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0962-2025Don't want to check this manually?
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