FDAFDA · Food and drugs·Recall number Z-1224-2022
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Published June 8, 2022 · Recall initiated: May 3, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software anomaly was identified.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Xomed, Inc.
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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