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Terminated

Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

FDA Recall Z-0770-2017 · Posted None

Recalling FirmNatus Medical Incorporated
Recall StatusTerminated
Product CodeLBI
Date Initiated2016-10-28
Date Terminated2021-01-15
Product Quantity2619 units (1925 units in the US and 694 units OUTSIDE the US)

Reason for Recall

neoBLUE blanket LED Phototherapy System distributed since release of the product in 2011 is recalled due to customer complaints regarding discoloration/ degradation of fiberoptic bundle at connection of pad and box.

Firm Action

Natus began sending the URGENT RECALL NOTIFICATION / FIELD SAFETY NOTICE neoBLUE blanket system performance letter dated October 27, 2016 and the Technical Bulletin to US customers on October 28, 2016. Natus plans to notify their international customers on December 2, 2016. Customers were informed in March 2015 of a potential issue of discoloration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoBLUE blanket light box. Included with that letter was a Technical Bulletin which described the issue and addressed many of your potential questions. The purpose of this current letter (dated October 27, 2016) is to communicate Natus' plan for a follow-on field correction for neoBLUE blanket systems shipped between 2011 through March 21, 2016 (Serial Numbers up to and including xxxx004282), and to remind customers of the instructions contained in the neoBLUE blanket Technical Bulletin. Natus is in the process of confirming an updated neoBLUE blanket configuration which will not be susceptible to the degradation described above. However, the date of project completion is uncertain at this time. Natus will contact customers when the new configuration is available, at which time Natus intend to initiate a field corrective action to replace or upgrade your device(s). Please contact Natus [email protected] if you have any further questions. Please call (800) 426-0353.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : including American Samoa and Guam, and in the following countries: Albania, Argentina, Australia, Austria, Bangladesh, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, Indonesia, Iraq, Israel, Italy, Korea, Kuwait, Latvia, Malaysia, Mongolia, Namibia, Netherlands, Nigeria, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Virgin Islands (British).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103589NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEMNatus Medical Incorporated · 2011-05-13

Official Source

View FDA Recall →

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

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