Medical device recalls Moderate risk

Ad-Tech Medical Instrument Corporation recalls AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

Recall date
September 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0220-2025
FDA classification
Class II
Brand / firm
Ad-Tech Medical Instrument Corporation
Sold / distributed
US Nationwide distribution in the states of CA, OH.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

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