PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 8, 2022 Initiated: May 3, 2022 #Z-1223-2022

Product Description

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

Reason for Recall

Software anomaly was identified.

Details

Recalling Firm
Medtronic Xomed, Inc.
Units Affected
18 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Location
Jacksonville, FL

Frequently Asked Questions

What product was recalled?
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2. Recalled by Medtronic Xomed, Inc.. Units affected: 18 units.
Why was this product recalled?
Software anomaly was identified.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1223-2022.