Recall Z-0220-2025 ยท GZL Electrode, Depth
Ad-Tech Medical Instrument Corporation
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
| Date | Oct 24, 2024 (initiated Sep 19, 2024) |
| Status | Completed |
| 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. |
| Root cause | Employee error |
| Action | AD-TECH issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/19/2024. The notice explained the problem with the devices, risk to health, and requested the consignee contact customer support to obtain an RMA to expedite the return of the affected product. For questions: contact your Ad-Tech Clinical Specialist. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of CA, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes Ad-Tech Medical Instrument Corporation, Apr 12, 2017 |