The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Photothera
FDA device recall Z-0420-2010 · posted 2009-11-24 · Terminated
Recall details
- Recalling firm
- Natus Medical Incorporated
- 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 taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LBI
- Quantity affected
- 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
- Date initiated
- 2009-10-01
- Date posted
- 2009-11-24
- Date terminated
- 2011-09-22
- Location
- Seattle, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NATUS BLUE LIGHT PHOTOTHERAPY UNIT (K022196) | Natus Medical, Inc. | 2002-09-19 |