Ad-Tech Medical recalls depth electrodes made through May 2019 due to MR environment safety risks. These devices are not approved for use in MRI settings, potentially causing harm.
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 depth electrodes made through May 2019 because they are not approved for use in MRI environments. This could lead to safety risks if used in magnetic resonance imaging procedures.
These electrodes are approved for use in the MR environment but are not actually approved for MRI settings. Using them in MRI procedures could cause harm due to magnetic field interactions.
Medical professionals using these electrodes in MRI settings are most at risk. Patients undergoing MRI procedures with these devices could face safety issues.
Check for depth electrodes with catalog numbers or lot numbers distributed through May 30, 2019. The product names include Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, and Wyler Sphenoidal Depth Electrodes.
Review catalog numbers and lot numbers to confirm if your device was made through May 30, 2019.
No, these electrodes are not approved for use in MRI settings despite being labeled as MR-compatible.
Check if your device was made through May 30, 2019. If so, contact Ad-Tech Medical for guidance.
The electrodes are approved for use in the MR environment but are not approved for MRI settings, creating a safety risk.
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-2407-2019 — Ad-Tech Medical Ad-Tech Medical Hello, I own a Ad-Tech Medical that is covered by recall Z-2407-2019 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.
