Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used i

FDA device recall Z-0769-2017 · posted 2016-12-15 · Terminated

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

The firm sent the Technical Bulletin to consignees who received the reliability updated neoBLUE blanket LED Phototherapy Systems between March 2016 to August 2016. The reliability update to prevent the early failure of the fiberoptic pads experienced by some customers on older systems. These failures on previous systems involved discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.

Action taken

Natus sent the Urgent Recall Notification/Field Safety Notice and Customer Reply Form (DOC-021042A), dated September 16, 2016 and the Technical Bulletin (DOC-021016) to US consignees via email. The letters and technical bulletin for foreign consignees was sent via email to the appropriate Natus Distribution Partner (DP) on November 7, 2016. US Customers can email the customer reply form to Natus_Quality_Progams@natus.com or fax to (847-949-6031). US Customers with questions can call Natus Technical Service at 888-496-2887. International customers should contact their local distributor with any questions.

Root cause

Device Design

Status

Terminated

Product code

LBI

Quantity affected

713 units total (403 units in US and 310 units outside US)

Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, ND, NJ, NM, NY, OH, OK, OR, PA

Date initiated

2016-09-16

Date posted

2016-12-15

Date terminated

2017-09-01

Location

Seattle, WA

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