Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED Phototherap

FDA device recall Z-1412-2015 · posted 2015-04-10 · Terminated

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

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. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

Action taken

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. Natus emailed the Distribution Partner (DP) letter to all Natus International Distribution 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. 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 pad. This procedure will prevent the complete degradation and therapy will not be compromised. U.S. customers should contact Natus Technical Service at 888-496-2887 with any questions regarding this notification. International customers should contact their local distributors or contact Natus Technical Service at (888) 496-2887 or Technical_Service@natus.com.

Root cause

Other

Status

Terminated

Product code

LBI

Quantity affected

2611 units (1911 units in the US and 700 units outside the US)

Distribution

distributed worldwide

Date initiated

2015-03-16

Date posted

2015-04-10

Date terminated

2016-12-20

Location

Seattle, WA

Related 510(k) clearances