Northgate Boston Scientific AUTOLITH TOUCH Lithotripter: Language Settings Issue
Recall of Northgate Technologies' Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter with Russian, Romanian, Slovak, and Czech language settings misconfigured for high/low power.
Lower-risk recall
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Contact the company
What happened, in plain English
Northgate Technologies recalls specific models of Boston Scientific AUTOLITH TOUCH lithotripters that have language settings for Russian, Romanian, Slovak, and Czech that incorrectly switch high and low power settings. This could lead to improper device operation if users are unaware of the setting changes. Read more at govinfonow.com/recall/61632-northgate-boston-scientific-autolith-touch-lithotripter-language-settings-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/61632-northgate-boston-scientific-autolith-touch-lithotripter-language-settings-issue · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0333-2022
Cite this page
“Northgate Boston Scientific AUTOLITH TOUCH Lithotripter: Language Settings Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61632-northgate-boston-scientific-autolith-touch-lithotripter-language-settings-issue. Based on FDA recall #Z-0333-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0333-2022%22&limit=1).
Why it’s dangerous
The device has language settings for Russian, Romanian, Slovak, and Czech that incorrectly switch high and low power settings. This could cause improper operation if users are unaware of the setting changes, potentially leading to ineffective treatment or device damage.
Who’s affected
Users of the recalled lithotripters with specific serial numbers (21578LAA to 21716CBA, and other ranges) purchased between February 2017 and October 2021 are affected. Medical professionals using these devices for kidney stone treatment are most at risk.
How to tell if you have this one
Check the serial number on the device, which falls within the listed ranges (e.g., 21578LAA to 21716CBA) and was purchased between February 14, 2017, and October 7, 2021.
- Brand
Northgate Technologies- Product
Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be- Category
Medical device
What to do — step by step
Check Serial Number
Identify the device's serial number to confirm it falls within the listed ranges (e.g., 21578LAA to 21716CBA).
Where it went and when
Where it was distributed
Distributed in Massachusetts.
FDA distribution: “US Distribution to state of MA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0333-2022 (October 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0333-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.