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Completed

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

FDA Recall Z-0221-2025 · Posted 2024-10-24

Recalling FirmAd-Tech Medical Instrument Corporation
Recall StatusCompleted
Product CodeGZL
Date Initiated2024-09-19
Product Quantity14 units

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.

Firm Action

AD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution in the states of CA, OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation · 2017-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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