Product Safety Recalls

Product Recall Tracker

DIXI MEDICAL USA Recall 89306

Description: The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

DIXI MEDICAL USA Recall 89306 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0537-2022
Event ID89306
Event DescriptionThe DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity2720 units
Recall ReasonPotential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Device Classification20220209
Device Code InfoAll lots UDI: 03664539000077
Center Classification Date20220128
Recall Initiation Date20211209
Recalling FirmDIXI MEDICAL USA
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.