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microTargeting™ Insertion Tube set

FHC, INC. · Model 66-IT-13-00813 · UDI-DI 00873263008133

GZL Prescription

510(k) clearances

227

Adverse events (3 deaths)

Recalls

Facilities

Description

microTargeting Single Electrode Insertion Tube Set, 1x, nonsterile Contains: IT(BP13): Insertion Tube - 194mm tube length, 1.83mm od, 1.6mm id PT(BP13): Protective Tube - 1.0mm id 1x Spacer Cleaning tool

Recalls

Date	Firm	Reason
2024-09-19	Ad-Tech Medical Instrument Corporation	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 p
2024-09-19	Ad-Tech Medical Instrument Corporation	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 p
2024-09-19	Ad-Tech Medical Instrument Corporation	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 p
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
2021-12-09	DIXI MEDICAL USA	Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.