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
Reported: June 22, 2016 Initiated: April 11, 2016 #Z-2001-2016
Product Description
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
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.
Details
- Recalling Firm
- Natus Medical Incorporated
- Units Affected
- 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, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.
- Location
- Seattle, WA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Natus Medical Incorporated. Units affected: 13541 units total (7840 units in the US and 5701 units outside the US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2016. Severity: Moderate. Recall number: Z-2001-2016.
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