Medical Device Patient Interface Recalled Due to Software Anomaly
Medtronic is recalling the NIM Vital Patient Interface 4.0 due to a software anomaly identified in the device. The recall affects 29 units distributed worldwide, including in the US and France.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The hazard—a software anomaly—is theoretical in nature with insufficient information about the specific risk. This fits the profile of a precautionary recall.
Plain-English summary
The product being recalled is the NIM Vital Patient Interface 4.0 (Model NIM4CPB1) with Software version 1.3.2, manufactured by Medtronic Xomed, Inc. A software anomaly was identified in the device.
The recall affects 29 units distributed worldwide, including in the US states of Texas, Colorado, and New Jersey, and in France. Specific lot numbers are identified in the FDA recall notice.
Healthcare facilities and users of this device should verify their inventory against the affected lot numbers and contact Medtronic Xomed, Inc. for further instructions regarding this Class II recall.
The recalled product
- Product
- NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
- Manufacturer
- Medtronic Xomed, Inc.
- Hazard
- software-anomaly
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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