Medtronic Xomed, Inc.: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Is my product affected?

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

• UPC 00763000395896
• UPC 00763000002978

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

What happened

Medtronic Xomed, Inc. is recalling 18 units of the NIM Vital Console 4.0 (Model Number NIM4CM01, Software version 1.3.2) due to a software anomaly that was identified in the device. The affected units were distributed worldwide, with specific distribution in the United States in Texas, Colorado, and New Jersey, as well as in France. The recalled devices are identified by their UDI/DI numbers 00763000395896 and 00763000002978, and multiple lot numbers are specified in the recall record.

The recall notice does not specify a remedy or recommended consumer action.

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: 18 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

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

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