FDAFDA · Food and drugs·Recall number Z-0221-2025
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Published October 30, 2024 · Recall initiated: September 19, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ad-Tech Medical Instrument Corporation
- Distributor
- US Nationwide distribution in the states of CA, OH.
- Lot
- UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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