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Terminated

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

FDA Recall Z-2001-2016 · Posted None

Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeLBI
Date Initiated2016-04-11
Date Terminated2016-12-14
Product Quantity13541 units total (7840 units in the US and 5701 units outside the US)

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.

Firm Action

The URGENT: FIELD SAFETY NOTICE PRODUCT LABELING CHANGE neoBLUE LED Phototherapy System, dated April 2016, was went to US customers between April 11, 2016 and April 27, 2016. Natus distribution partners outside the US will receive the Letter to Distributors and they are requested to contact their downstream customers to distribute the information. The estimated date of notifying international consignees is May 31, 2016. Enclosed with this letter, customers would receive: 1) Quick Guides (2 each) which provide operating steps, information about measuring intensity, and warnings (PN 051693) 2) User manual addendum 3) Customer reply form Natus requests that this information be distributed to all associated parties within your organization that use or service this product. Please note: this communication is in addition to any prior labeling changes that you may have received from Natus. Customers should submit the Reply Form via fax to 847-949-6031 or email to mailto:[email protected]. If there are any questions regarding this letter and addendum, please call Natus Technical Service at 888-496-2887.

Root Cause

Labeling False and Misleading

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022196NATUS BLUE LIGHT PHOTOTHERAPY UNITNatus Medical, Inc. · 2002-09-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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