NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.

FDA device recall Z-2409-2024 · posted 2024-07-24 · Open, Classified

Recall details

Recalling firm

Medtronic Xomed, Inc.

Reason for recall

Potential for false negative response on the NIM Vital Nerve Monitoring System

Action taken

Medtronic Xomed notified consignees on 06/24/2024 via letter. The letter instructed consignees that Medtronic has developed a NIM" Vital software version 1.5.4 to address this issue. Consignees were also instructed to identify affected products within inventory, share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action, and maintain a copy of this letter for your records. The respective Medtronic Representative will contact you to install the new software version 1.5.4 for correction of the impacted product in your possession. Additionally, consignees were asked to complete and return the customer confirmation form enclosed via email to neuro.quality@medtronic.com. Medtronic Xomed sent consignees a follow up letter with updated information on 08/22/2024. The update provided additional information and instructions to mitigate the risk with affected devices.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GWF

Quantity affected

7,804 units

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia,

Date initiated

2024-06-24

Date posted

2024-07-24

Location

Jacksonville, FL

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