Recall Z-0149-2016 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
| Date | Oct 21, 2015 (initiated Aug 5, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | No Marketing Application |
| Action | 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 dis |
| Quantity | 4560 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022196 | NATUS BLUE LIGHT PHOTOTHERAPY UNIT Natus Medical, Inc., Sep 19, 2002 |