AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
This recall is currently active, issued October 24, 2024. It was issued by Ad-Tech Medical Instrument Corporation.
- Recall Initiated
- September 19, 2024
- Posted
- October 24, 2024
- Recall Number
- Z-0221-2025
- Quantity
- 14 units
- Firm Location
- Oak Creek, WI
- Official Source
- View on FDA website ↗
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
US Nationwide distribution in the states of CA, OH.
Lot / Code Info
UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
Root Cause
Employee error
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.