Ad-Tech Medical Instrument Corporation: AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

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.

Details from the source

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. Quantity: 2 units Lot/code info: UDI/DI 00841823107510, Lot Number 170052 858859860

UPC codes

00841823107510

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.