Northgate Technologies, Inc. recalls Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be us…
- Recall date
- October 25, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0333-2022
- FDA classification
- Class II
- Brand / firm
- Northgate Technologies, Inc.
- Sold / distributed
- US Distribution to state of MA.
Why it was recalled
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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