Recall Z-2001-2016 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
| Date | Apr 11, 2016 |
| Status | Terminated |
| Reason | The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device. |
| Root cause | Labeling False and Misleading |
| Action | The URGENT: FIELD SAFETY NOTICE PRODUCT LABELING CHANGE neoBLUE LED Phototherapy System, dated April 2016, was went to US customers between April 11, 2016 and April 27, 2016. Natus distribution partners outside the US will receive the Letter to Distributors and they are requested to contact their downstream customers to distribute the information. The estimated date of notifying international consignees is May 31, 2016. Enclosed with this letter, customers would receive: 1) Quick Guides (2 each) which provide operating steps, information about measuring intensity, and warnings (PN 051693) |
| Quantity | 13541 units total (7840 units in the US and 5701 units outside the US) |
| Distribution | Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republ |
| 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 |