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Recall Observatory FDA recall evidence

Device product

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

Z-0221-2025

September 19, 2024

Class II

Product summary

Firm
Ad-Tech Medical Instrument Corporation
Event
Event 95414
Status
Completed
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-0221-2025

Official wording

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.

Code information: UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881

Distribution pattern: US Nationwide distribution in the states of CA, OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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