Recall Z-1224-2022— Medtronic Xomed, Inc.

Name: FDA recall Z-1224-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Class II · Ongoing

Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2022-05-03. It names one FDA 510(k) clearance: K200759. Product: NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2. Reason: Software anomaly was identified..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-05-03
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K200759 — NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc.·cleared 2020-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Software anomaly was identified.

Data sourced from openFDA. This site is unofficial and independent of the FDA.