Recall Z-1412-2015 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small
| Date | Apr 10, 2015 (initiated Mar 16, 2015) |
| Status | Terminated |
| Reason | neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box. |
| Root cause | Other |
| Action | Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual. The technical bulletin asks the customer to visuall |
| Quantity | 2611 units (1911 units in the US and 700 units outside the US) |
| Distribution | distributed worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103589 | NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM Natus Medical Incorporated, May 13, 2011 |