Home / Recalls / Medtronic Xomed, Inc. / Z-1223-2022

Z-1223-2022 Class II Ongoing

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

Recall Details

Product Type
Devices
Report Date
June 8, 2022
Initiation Date
May 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18 units

Product Description

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

Reason for Recall

Software anomaly was identified.

Distribution Pattern

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

Code Information

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.

Other recalls by Medtronic Xomed, Inc.

  • Z-2461-2025 Class II — IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. Th (July 17, 2025)
  • Z-1623-2025 Class II — NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; (March 10, 2025)
  • Z-3130-2024 Class II — Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 (July 5, 2024)
  • Z-2409-2024 Class I — NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi (June 24, 2024)
  • Z-0696-2024 Class II — NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970 (November 7, 2023)
  • Z-1224-2022 Class II — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 (May 3, 2022)
  • Z-1521-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) (April 29, 2022)
  • Z-1519-2022 Class I — NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 (April 29, 2022)
  • Z-1520-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) RE (April 29, 2022)
  • Z-0743-2022 Class II — NIM TRIVANTAGE EMG Endotracheal Tube (December 22, 2021)