Recall Z-0770-2017 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 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 b
| Date | Oct 28, 2016 |
| Status | Terminated |
| Reason | neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box. |
| Root cause | Device Design |
| Action | Natus began sending the URGENT RECALL NOTIFICATION / FIELD SAFETY NOTICE neoBLUE blanket system performance letter dated October 27, 2016 and the Technical Bulletin to US customers on October 28, 2016. Natus plans to notify their international customers on December 2, 2016. Customers were informed in March 2015 of a potential issue of discoloration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoBLUE blanket light box. Included with that letter was a Technical Bulletin which described the issue and addressed many of your potential questions. T |
| Quantity | 2619 units (1925 units in the US and 694 units OUTSIDE the US) |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries: Albania, Argentina, Australia, Austria, Bangladesh, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong |
| 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 |