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Northgate Technologies, Inc. recalls Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be us
Recalled December 15, 2021 · FDA recall Z-0333-2022 · Northgate Technologies
Hazard
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. · FDA Class II
Units
2,277 devices
Sold at
US Distribution to state of MA.
Description
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Product
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.
Manufacturer(s)
Northgate Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →