FDA Medical Device Recalls (openFDA)
Natus Medical Incorporated: The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
- Recall number
- Z-0420-2010
- Recalling firm
- Natus Medical Incorporated
- Product
- The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System"
- Status
- Terminated
- Initiated
- 2009-10-01
- Posted
- 2009-11-24
- Terminated
- 2011-09-22
- 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, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K022196"]
- PMA numbers
- not on file
- Product code
- LBI
- Firm FEI
- 3018859
- Firm city
- Seattle
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28