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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90163

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 03, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Xomed, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1223-2022
Recall number
Z-1223-2022
Initiated
May 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Xomed, Inc.
Quantity
18 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software anomaly was identified.

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.

device · product 2 of 2

NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Z-1224-2022
Recall number
Z-1224-2022
Initiated
May 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Xomed, Inc.
Quantity
29 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software anomaly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software anomaly was identified.

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

Distribution pattern

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