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Open, Classified

NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

FDA Recall Z-1223-2022 · Posted 2022-06-02

Recalling FirmMedtronic Xomed, Inc.
Recall StatusOpen, Classified
Product CodeGWF
Date Initiated2022-05-03
Product Quantity18 units

Reason for Recall

Software anomaly was identified.

Firm Action

The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.

Root Cause

Software Design Change

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. · 2020-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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