AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
FDA device recall Z-0221-2025 · posted 2024-10-24 · Completed
Recall details
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Completed
- Product code
- GZL
- Quantity affected
- 14 units
- Distribution
- US Nationwide distribution in the states of CA, OH.
- Date initiated
- 2024-09-19
- Date posted
- 2024-10-24
- Location
- Oak Creek, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (K163355) | Ad-Tech Medical Instrument Corporation | 2017-04-12 |