Recall Z-0420-2010 ยท LBI Unit, Neonatal Phototherapy
Natus Medical Incorporated
The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
| Date | Nov 24, 2009 (initiated Oct 1, 2009) |
| Status | Terminated |
| Reason | The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported. |
| Root cause | Device Design |
| Action | On 10/1/09 Natus notified domestic consignees by Urgent Product Advisory Notice letter that advised them of the issue, instructed them to inspect the clamps, and included pictures of the affected clamp. Consignees are instructed to return the recalled clamps for a new replacement to be shipped by Natus. International distribution partners were notified by letter on 10/1/2009 and instructed to identify and contact their consignees. Replacements will be sent to the distribution partner for their consignees. |
| Quantity | 2127 |
| Distribution | Worldwide distribution: USA, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Por |
| 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 |