AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Elect...
FDA Recall #Z-0221-2025 — Class II — September 19, 2024
Product Description
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
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.
Recalling Firm
Ad-Tech Medical Instrument Corporation — Oak Creek, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
14 units
Distribution
US Nationwide distribution in the states of CA, OH.
Code Information
UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated