Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or in CommerceĢ611 units (1911 units in the US and 700 units outside the US)ġ A record in this database is created when a firm initiates a correction or removal action. customers should contact Natus Technical Service at 88 with any questions regarding this notification. This procedure will prevent the complete degradation and therapy will not be compromised. The technical bulletin asks the customer to visually and tactilely inspect the fiber optic cable connector before use, and to call Natus if they notice a failing Natus emailed the Distribution Partner (DP) letter to all Natus Internationalĭistribution Partners, requiring that they notify their customers (at Biomedical Department and Neonatal Intensive Care Unit) with copies of the Field Safety Notice, customer letter, the Technical Bulletin, Instructions for Use, and Service Manual.
#Natus neoblue manual
Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. Most Effective Degradation of Bilirubin1 Meets AAP Guidelines for Intensive phototherapy2 Blue LEDs emit most of their light in the 450-475 nm spectrum. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box. 87 REQUEST QUOTE Description WARRANTY INFORMATION The Natus NeoBlue LED Phototherapy incorporates optimal blue LED technology for the treatment of newborn jaundice. Natus sent the PRODUCT RELIABILITY ALERT neoBLUE blanket system performance along with an attached Technical Bulletin, Instructions for Use, and Service Manual to consignees via email during the week of March 16, 2015. NeoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. Natus neoBLUE blanket LED Phototherapy system which includes the following items:Ġ06224 neoBLUE blanket LED Phototherapy Systems with Large blanket/padĠ06895 neoBLUE blanket LED Phototherapy Systems with Small blanket/padĠ07299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EURĠ07300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EURĠ07296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UKĠ07298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UKĠ07301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUSĠ07302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS Unit, neonatal phototherapy - Product Code LBI Class 2 Device Recall Natus neoBLUE blanket LED Phototherapy system
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