Z-0221-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2024
- Initiation Date
- September 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
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.
Distribution Pattern
US Nationwide distribution in the states of CA, OH.
Code Information
UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881