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Ad-Tech Medical Instrument Corporation recalls AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Recalled October 30, 2024 · FDA recall Z-0221-2025 · Ad-Tech Medical Instrument
Hazard
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. · FDA Class II
Units
14 units
Sold at
US Nationwide distribution in the states of CA, OH.
Description
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.
Product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Manufacturer(s)
Ad-Tech Medical Instrument Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →