Device product
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Z-0221-2025
Product summary
- 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
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.