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

• Reason
• Affected products

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