FDA recall Z-1223-2022

Medtronic Xomed, Inc. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2022-05-03
Report date: 2022-06-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jacksonville, FL, United States

Primary source

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