Z-0220-2025 Class II Ongoing

Recalled by Ad-Tech Medical Instrument Corporation — Oak Creek, WI

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
September 19, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

Product Description

AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-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 Pattern

US Nationwide distribution in the states of CA, OH.

Code Information

UDI/DI 00841823107589, Lot Number 169260 858859860, 169258 858859860