Home / Recalls / Medtronic Xomed, Inc. / Z-1224-2022

Z-1224-2022 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
29 units

Product Description

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) 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: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013

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-1223-2022 Class II — NIM Vital Console 4.0 (P/N: NIM4CM01) 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)