Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 2003 and 2008. Catalog Part Number 010066. Top

FDA device recall Z-1924-2017 · posted 2017-04-14 · Terminated

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so it will eliminate the possibility that a neoBLUE system may have a replacement board installed which allows it to be used at a higher overall light intensity than the devices were originally cleared to deliver.

Action taken

On April 3, 2017, Natus sent the URGENT: RECALL NOTIFICATION 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, and the Reply Form to the U.S. customers. U.S. Customers are advised to follow four steps process to receive replacement lights and return affected light back to Natus in Seattle, WA for destruction. Customers should scan and email completed Reply Form to Natus_Quality_Programs@natus.com or FAX to 847-949-6031. On April 4, 2017, Natus sent the URGENT MEDICAL DEVICE RECALL/EXCHANGE 2nd Generation neoBLUE LED Phototherapy Systems letter, dated March 2017, Reply Form, Instructions to Disable neoBLUE 2 Light, neoBLUE 2 Systems Serial Number List For Their Territory to international Distribution Partners. Downstream international customers are instructed to return the affected neoBLUE lights to their Distribution Partners. International Distribution Partners follow the Instructions to Disable neoBLUE2 lights (DOC- 019983 rev A) and destroy all affected neoBLUE lights that they recover from downstream international customers. Distribution Partners can contact Natus Technical Service at 1-888-496-2887, or e-mail the Reply Form to Natus_Quality_Programs@natus.com or via fax to 847-949-6031.

Root cause

Component change control

Status

Terminated

Product code

LBI

Quantity affected

4,371 units (3,285 units in the US and 1,086 units outside of the US)

Distribution

Worldwide Distribution - US Nationwide and in the following countries: Argentina, Australia, Austria, Belgium, Bermuda, Canada, Colombia, Croatia, Denmark, Germany, Greece, Hungary, India, Indonesia,

Date initiated

2017-04-03

Date posted

2017-04-14

Date terminated

2019-08-13

Location

Seattle, WA

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