Recall of Northgate Technologies' Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter with Russian, Romanian, Slovak, and Czech language settings misconfigured for high/low power.
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
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.
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.
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.
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.
Identify the device's serial number to confirm it falls within the listed ranges (e.g., 21578LAA to 21716CBA).
The device has language settings for Russian, Romanian, Slovak, and Czech that incorrectly switch high and low power settings, which could lead to improper operation.
Check the serial number to see if it falls within the listed ranges. If it does, contact Northgate Technologies for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Northgate Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0333-2022 — Northgate Technologies Northgate Technologies Hello, I own a Northgate Technologies that is covered by recall Z-0333-2022 from Northgate Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
