# FDA recall Z-0333-2022

> **Northgate Technologies, Inc.** · Class II · device recall initiated 2021-10-25.

## 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.

## Reason for recall

The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.

## Distribution

US Distribution to state of MA.

## Key facts

- **Recall number:** Z-0333-2022
- **Recalling firm:** Northgate Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-25
- **Report date:** 2021-12-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elgin, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0333-2022

## Citation

> AI Analytics. FDA recall Z-0333-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0333-2022. Source: US FDA. Licensed CC0.

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