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neoBLUE LED Phototherapy (neoBLUE 2 with replacement board) (2014-11-05)

Starting date:
November 5, 2014
Posting date:
November 21, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42275

Recalled products

  1. neoBLUE LED Phototherapy (neoBLUE 2 with replacement board)

Reason

Due to increased efficiency of LED manufacture, the replacement LED boards (part number 001840) for the neoBLUE 2 systems contain LEDs which have higher intensity than those in the original device. As a result, the light intensity may need to be adjusted using the device potentiometer or through treatment distance.  Natus is sending a letter and a copy of the latest technical bulletin to all customers who have purchased a replacement LED board (P/N 001840). Natus will be calling each customer that received the new board to verify the receipt of this letter.

Affected products

A. neoBLUE LED Phototherapy (neoBLUE 2 with replacement board)

Lot or serial number
  • Serial# 10507 to 17919
Model or catalog number
  • 010066
Companies
Manufacturer
Natus Medical Incorporated,
5900 First Avenue South,
Seattle
98108
Washington
UNITED STATES