FDA Device recall Z-0219-2025
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
- FDA Device
- Class II
- completed
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode by Ad Tech Medical Instrument, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0219-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2024-09-19 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ad Tech Medical Instrument |
| Distribution | US |
Product
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
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.
Identifiers
| code_info | UDI/DI 00841823107510, Lot Number 170052 858859860 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0219-2025%22
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