RecallRadar

FDA Device recall Z-1223-2022

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

On 2022-06-08 the FDA classified a Class II recall of NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 by Medtronic Xomed, citing software anomaly was identified.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1223-2022
ClassificationClass II
Statusongoing
Initiated2022-05-03
Published2022-06-08
Last updated2026-09-13 11:56 UTC
CompanyMedtronic Xomed
DistributionUS

Product

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

Reason

Software anomaly was identified.

Identifiers

code_info
Model Number: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1223-2022%22

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