NIM Vital Patient Interface 4.0 recall: Software Issue
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Why was NIM Vital Patient Interface 4.0 recalled?
Software anomaly was identified.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 29 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- Recall date
- June 8, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)