NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Summary
The FDA issued a Class II for NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 by Medtronic Xomed, Inc.. Reason: Software anomaly was identified..
Details
Source
Device Recall
External ID
Z-1224-2022
Action Date
2022-06-08
Status
Ongoing
Category
device
Product Description
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Lot/Code Info: Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Quantity Affected: 29 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-03
Company
Jacksonville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Xomed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Xomed, Inc. have FDA actions?
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1224-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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