medical Class II Updated 2022-06-08

Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Sof

Recalled Product

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


Hazard / Issue

Software anomaly was identified.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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