Recall Z-0221-2025— Ad-Tech Medical Instrument Corporation

Name: FDA recall Z-0221-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-19

Class II · Completed

Class II FDA medical device recall by Ad-Tech Medical Instrument Corporation, initiated 2024-09-19. It names one FDA 510(k) clearance: K163355. Product: AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode. Reason: 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
Classification: Class II
Status: Completed
Initiated: 2024-09-19
Firm location: Oak Creek, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation·cleared 2017-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.