The Recall Desk
ModerateFDA (Devices)·Z-2001-2016·Announced 2016-06-22

Natus neoBLUE Phototherapy System Recall for Warning Label Update

Natus Medical is recalling 13,541 neoBLUE Phototherapy systems to add a warning statement to the instructions and provide a laminated Quick Guide for each device.

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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the hazard is not likely to cause serious adverse health consequences but may cause temporary or medically reversible harm. The action is primarily documentation-related (adding warnings and guides).

Plain-English summary

Natus Medical Incorporated is recalling the neoBLUE Phototherapy system, Catalogue Part Number 010066, which is used to treat neonatal hyperbilirubinemia. The recall involves 13,541 units in total, with 7,840 units distributed in the United States and 5,701 units distributed outside the United States. The affected devices were distributed worldwide, including in the US, American Samoa, Guam, Puerto Rico, and numerous international locations.

The recall is being conducted to add a warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System. Additionally, Natus Medical will provide a laminated Quick Guide to be affixed to each device. The source text does not specify the exact nature of the hazard or the reason for the warning statement beyond the need to update the documentation and provide the guide.

Healthcare facilities and consumers with these devices should check their serial numbers against the list provided by the FDA. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
Manufacturer
Natus Medical Incorporated
Category
Medical Device — Neonatal Phototherapy
Hazard

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)

  • Serial numbers of units distributed in American Samoa
  • Guam
  • Puerto Rico and in the US: .22938
  • .23282
  • .23283
  • .23289
  • .23291
  • .23302
  • .23307
  • .23471
  • .23473
  • .23478
  • .23479
  • .23480
  • .23481
  • .23483
  • .23538
  • .23697
  • .23708
  • .23887

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

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Same hazard · documentation update

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