Medtronic Xomed, Inc.: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2

Is my product affected?

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

• UPC 00763000002985
• UPC 00763000395902

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Xomed, Inc. is recalling 29 units of the NIM Vital Patient Interface 4.0 (Model Number NIM4CPB1) with software version 1.3.2 due to a software anomaly that was identified in the device. The affected devices have specific lot numbers and UDI/DI codes, and were distributed worldwide, including in Texas, Colorado, New Jersey, and France.

The recall record does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Software anomaly was identified.

Details from the source

Reason for recall: Software anomaly was identified. Distribution: Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France. Quantity: 29 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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