Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 0
FDA device recall Z-0149-2016 · posted 2015-10-21 · Terminated
Recall details
- Recalling firm
- Natus Medical Incorporated
- Reason for recall
- The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
- Action taken
- Natus Medical starting sending the Product Labeling Change NeoBlue LED Phototherapy System letter, dated August 2015, to all affected customers. The firm also attached the electronic copy of the revised User Manual with the letter. Customers are informed that the user and service manuals related to intensity for the neoBLUE 3 system are revised. Also, while the neoBLUE system does allow the light output to be adjusted with the potentiometers to accommodate different treatment heights, the firm removed the phrase "adjustable to >50 W/cm/nm" from the specifications. If you would like a CD disk containing the updated User Manual and the Service Manual at no charge, please call Natus Technical Service at 888-496-2887.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- LBI
- Quantity affected
- 4560 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-08-05
- Date posted
- 2015-10-21
- Date terminated
- 2016-03-17
- Location
- Seattle, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NATUS BLUE LIGHT PHOTOTHERAPY UNIT (K022196) | Natus Medical, Inc. | 2002-09-19 |