Recall Z-1924-2017 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top Assembly Part Numbers: 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Device is used to provide treatment for neonatal hyperbilirubinemia.
| Date | Apr 14, 2017 (initiated Apr 3, 2017) |
| Status | Terminated |
| Reason | The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver. |
| Root cause | Component change control |
| Action | On April 3, 2017, Natus sent the URGENT: RECALL NOTIFICATION 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, and the Reply Form to the U.S. customers. U.S. Customers are advised to follow four steps process to receive replacement lights and return affected light back to Natus in Seattle, WA for destruction. Customers should scan and email completed Reply Form to Natus_Quality_Programs@natus.com or FAX to 847-949-6031. On April 4, 2017, Natus sent the URGENT MEDICAL DEVICE RECALL/EXCHANGE 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, Repl |
| Quantity | 4,371 units (3,285 units in the US and 1,086 units outside of the US) |
| Distribution | Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Morocco, Norway, Peru, Philippines, Poland, Portugal |
| 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 |