Recall Z-2001-2016
Natus Medical Incorporated · initiated April 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Serial numbers of units distributed in American Samoa, Guam, Puerto Rico and in the US: .22938, .23282, .23283, .23289, .23291, .23302, .23307, .23471, .23473, .23478, .23479, .23480, .23481, .23483, .23538, .23697, .23708, .23887, .23888, .23895, .23916, .23939, .23968, .23969, .23972, .23983, .23993, .23994, .23998, 040756-1, 040756-2, 1, 10090, 10507, 10559, 10592, 10595, 10597, 10598, 10613, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10642, 10643, 10645, 10646, 10659, 10660, 10661, 10662, 10663, 10666, 10667, 10668, 10671, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10684, 10685, 10686, 10687, 10688, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10709, 10710, 10711, 10712, 10713, 10714, 10715, 10716, 10717, 10718, 10719, 10725, 10727, 10728, 10730, 10731, 10732, 10734, 10739, 10740, 10743, 10744, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 10768, 10771, 10773, 10774, 10775, 10776, 10777, 10778, 10779, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10791, 10793, 10794, 10795, 10796, 10797, 10799, 10800, 10824, 10825, 10826, 10841, 10842, 10843, 10844, 10846, 10847, 10848, 10849, 10850, 10851, 10852, 10853, 10854…
Reason for recall
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.
FDA-determined cause: Labeling False and Misleading
Action taken
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) 2) User manual addendum 3) Customer reply form Natus requests that this information be distributed to all associated parties within your organization that use or service this product. Please note: this communication is in addition to any prior labeling changes that you may have received from Natus. Customers should submit the Reply Form via fax to 847-949-6031 or email to mailto:Natus_Quality_Programs@natus.com. If there are any questions regarding this letter and addendum, please call Natus Technical Service at 888-496-2887.
Details
- Recall number
- Z-2001-2016
- Initiated
- April 11, 2016
- Terminated
- December 14, 2016
- Product code
- LBI – Unit, Neonatal Phototherapy
- 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 Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India…
- Recalling firm
- Natus Medical Incorporated, Seattle, WA