Ad-Tech Medical Instrument Corporation is recalling 20 units of various A-Style SD Depth Electrodes, including 4-contact, 6-contact, and 8-contact models. These medical devices are being recalled because they were incorrectly labeled with an "MR Conditional" symbol instead of the required "MR Unsafe" symbol. This means the electrodes are not safe for use in an MRI environment, despite what the label indicates. The affected products were distributed in California and Ohio.
The incorrect label suggests these electrodes can be safely used during an MRI under certain conditions, when they are actually unsafe. If a patient with these electrodes undergoes an MRI, it could lead to serious medical complications or injury due to the device's interaction with the magnetic resonance environment.
Correction of labeling discrepancy and potential return/replacement.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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