Natus neoBLUE Phototherapy Systems Recalled for Fiberoptic Pad Failure
Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to early failure of fiberoptic pads, which can cause discoloration and melting at the connector.
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, and the source describes a reliability issue (discoloration and melting) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Natus Medical Incorporated is recalling Updated Natus neoBLUE blanket LED Phototherapy Systems. The recall involves 713 units distributed worldwide, including 403 units in the United States and 310 units in other countries. The affected systems provide phototherapy underneath infants and can be used in bassinets, open beds, radiant warmers, incubators, or while holding the infant.
The recall is due to a reliability issue where the fiberoptic pads may fail early. This failure involves discoloration and melting of the fiberoptic bundle at the connector that is inserted into the neoBLUE blanket light box. The firm sent a Technical Bulletin to consignees who received these reliability-updated systems between March 2016 and August 2016 to address this issue.
Healthcare facilities and consumers should check their serial numbers against the list provided in the official recall notice. Affected part numbers include 006244, 006254, 006895, 007299, 007300, 007296, 007298, 007301, and 007302. Users should contact Natus Medical Incorporated for instructions on how to proceed with the recall.
The recalled product
- Product
- Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx00
- Manufacturer
- Natus Medical Incorporated
- Category
- Medical Device — Phototherapy
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)
- 004330
- 004349
- 004360
- 004361
- 004362
- 004363
- 004364
- 004365
- 004366
- 004367
- 004369
- 004370
- 004371
- 004417
- 004421
- 004426
- 004436
- 004437
- 004443
- 004448
Distribution
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