Data Foundry

Medical device recalls 2022

NIM Vital Console 4 — Class II medical device recall Z-1223-2022

Ongoing recall by Medtronic Xomed, Inc., reported 2022-06-08, distributed nationwide. Software anomaly was identified.

Recall numberZ-1223-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedtronic Xomed, Inc., Jacksonville, FL, United States
Recall initiated2022-05-03
Classified2022-06-02
Reported by FDA2022-06-08
DistributedNationwide (US)
Countries outside the USFR
Quantity18 units
Reason classessoftware
UPC / GTIN / UDI-DI00763000002978, 00763000395896
Lot numbersC1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223
Model numbersNIM4CM01

Product

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

Reason for recall

Software anomaly was identified.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1223-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.