The Recall Desk
ModerateFDA (Devices)·Z-1224-2022·Announced 2022-06-08

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.
Category
Medical Device — Patient Monitoring
Hazard
Affected units
29

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.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Xomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Xomed, Inc.

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Same hazard · software anomaly

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