Z-1223-2022Class II

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

Name: Z-1223-2022 NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Creator: Medtronic Xomed, Inc.
Published: 2022-05-03
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2022-05-03 / Open, Classified / root cause: software

FDA source

Medtronic Xomed, Inc. began a recall of NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 on 2022-05-03. FDA classified it as Class II and gives the reason as "Software anomaly was identified". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1223-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-03
Posted: 2022-06-02
Recalling firm: Medtronic Xomed, Inc.
Product: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Product code: GWF Stimulator, Electrical, Evoked Response
Reason for recall: Software anomaly was identified.
Root cause tag: software
FDA root cause: Software Design Change
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.
Quantity in commerce: 18 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Product codes and lots: Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1223-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1223-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02
Z-1224-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-02

Product code GWF

K200759Class IINIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. / cleared 2020-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)