Ad-Tech Medical Instrument Corporation: Device Recall

Recall Details

Recall Number

Z-0221-2025

Classification

Class II

Product Type

Device

Recalling Firm

Ad-Tech Medical Instrument Corporation

Status

Ongoing

Date Initiated

09/19/2024

Location

Oak Creek, WI, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

14 units

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.

Product Description

AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode

Distribution Pattern

US Nationwide distribution in the states of CA, OH.

Other Recalls by Ad-Tech Medical Instrument Corporation

• Class II: Risk 09/19/2024
  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.
• Class II: Risk 09/19/2024
  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.

View all recalls by Ad-Tech Medical Instrument Corporation →