Class II

Medical Device Recall: AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation · September 19, 2024

Reason for Recall

Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.

Distribution

US Nationwide distribution in the states of CA, OH.

States Affected

NATIONWIDE

Quantity Affected

14 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0221-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.