FDA recall Z-0221-2025

Ad-Tech Medical Instrument Corporation · Class II · device

Product

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

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.

Key facts

Status
Completed
Initiation date
2024-09-19
Report date
2024-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oak Creek, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2025