FDA-Device2021-12-15Class II
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
Northgate Technologies, Inc.
Hazard
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Sold states
US Distribution to state of MA.
Affected count
2,277 devices
Manufactured in
1591 Scottsdale Ct, N/A, Elgin, IL, United States
Products
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0333-2022Don'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