FDA-Device2022-06-08Class II

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

Medtronic Xomed, Inc.
Hazard

Software anomaly was identified.

Sold states
Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Affected count
18 units
Manufactured in
6743 Southpoint Dr N, N/A, Jacksonville, FL, United States
Products
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2022

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