Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 31, 2014
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a hig…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Natus Medical Incorporated recalled Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototh… - a moderate-severity action.
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototh… was recalled by Natus Medical Incorporated in December 31, 2014. Reason: Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subjec…. Check the official notice for the remedy. Verify recall #Z-0847-2015 with the FDA Devices before acting.
The recall
Natus Medical Incorporated issued this moderate-severity FDA Devices recall-Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subjec….
- Moderate
- severity level
- Class II
- classification
- December 31, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0847-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0847-2015) was formally reported on December 31, 2014, with the manufacturer initiating the action on November 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Natus Medical Incorporated is listed as the recalling firm, operating out of Seattle, WA. Federal records list the affected scope as 1907 total (1413 in US and 494 international).
The documented reason for this recall is: Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the orig… Distribution data in the federal record shows the product reached: worldwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1907 total (1413 in US and 494 international)
Related Recalls
6
3 from same agency
Product description
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Reason for recall
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0847-2015 |
| Date reported | December 31, 2014 |
| Date initiated | November 19, 2014 |
| Recalling firm | Natus Medical Incorporated |
| Firm location | Seattle, WA |
| Affected scope | 1907 total (1413 in US and 494 international) |
| Distribution | worldwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0847-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.. Recalled by Natus Medical Incorporated. Units affected: 1907 total (1413 in US and 494 international).
Why was this product recalled? ▼
Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the system will exhibit a higher light intensity output than the original device. While some customers may prefer using these lights at the higher intensity levels, some are concerned that patients may receive more intensity than desired.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0847-2015.
Where was the recalled product distributed? ▼
Distribution: worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0847-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 31, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.