Medtronic Xomed, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1223-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 3, 2022

Date Posted: June 8, 2022

Recall Number: Z-1223-2022

Event ID: 90163

Reason for Recall:

Software anomaly was identified.

Status: Ongoing

Product Quantity: 18 units

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated