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.
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: 14 units Lot/code info: UDI/DI 00841823107688, Lot Number 168788 855856857, 172999 873874875R, 174915 879880881
00841823107688
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.