Ad-Tech Medical recalls dual-sided subdural electrodes sold through May 2019 due to MR environment safety risks. These devices are approved for use in MRI but not intended for that purpose.
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Ad-Tech Medical is recalling dual-sided subdural electrodes made through May 2019 because they are approved for MRI use but not intended for that purpose. This could lead to safety risks if used in MRI environments.
The electrodes are approved for use in MRI environments but were not designed for that purpose. This mismatch could cause safety issues if the devices are used in MRI settings where they are not intended to be.
Medical professionals using these electrodes in MRI settings may be affected. Patients receiving these electrodes during surgery could be at risk if exposed to MRI environments.
Look for dual-sided subdural electrodes with catalog numbers or lot numbers distributed through May 30, 2019. The product name includes 'Wyler Subdural Electrodes' and 'Dual-Sided Interhemispheric, Grid, Intraoperative, Strip'.
Identify if your electrodes have catalog numbers or lot numbers distributed through May 30, 2019.
No, these electrodes are approved for use in MRI environments but were not designed for that purpose, which could create safety risks.
The recall does not specify a remedy, so check if your electrodes were distributed through May 30, 2019 and contact the manufacturer for guidance.
The recall indicates a potential safety risk if used in MRI environments, but no specific injury mechanism is described.
We’ve drafted a message you can send Ad-Tech Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2406-2019 — Ad-Tech Medical Ad-Tech Medical Hello, I own a Ad-Tech Medical that is covered by recall Z-2406-2019 from Ad-Tech Medical. 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.
