| | Class 2 Recall
Natus Blue Light, neoBLUE |  |
| Date Posted |
November 24, 2009 |
| Recall Number |
Z-0420-2010 |
| Product |
The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System" |
| Code Information |
Catalogue / Part Numbers:
010101 (110V, US, new);
010101R (110V, US, refurbish);
010102 (230V, UK, new);
010102R (230V, UK, refurbish);
010103 (230V, EUR, new);
010103R (230V, EUR, refurbish);
010104 (230V, EUR, new);
010104R (230V, EUR, refurbish).
AFFECTED SERIAL NUMBERS:
60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656.
|
Recalling Firm/
Manufacturer |
Natus Medical Incorporated
5900 1st Ave S
Seattle, Washington 98108-3248 |
Reason for
Recall |
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.
|
| 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 in Commerce |
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, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK |
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