NIM Vital Console 4.0 recall: Software Issue
NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
Why was NIM Vital Console 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: NIM4CM01; UDI/DI: 00763000395896, lot numbers: C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223 and 00763000002978, lot numbers: C1915048, C1915078, C1915099, C1915188, C2026207, C2026233, C2026320, C2026335, C2026354, C2026376, C2110046, C2110089, C2110131, C2110196, C2110198, C2110208, C2110217, C2110223.
- Product
- NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 18 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)