FDA-Device2024-10-30Class II
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Ad-Tech Medical Instrument Corporation
Hazard
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.
Sold states
US Nationwide distribution in the states of CA, OH.
Affected count
4 units
Manufactured in
400 W Oakview Pkwy, N/A, Oak Creek, WI, United States
Products
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0220-2025Don't want to check this manually?
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