The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX00

FDA device recall Z-0056-2017 · posted 2016-10-07 · Terminated

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.

Action taken

Natus sent an Urgent Notification Field Safety Notice on August 25, 2016 to all affected customers. Customers are asked to inspect the quality of the welds and wheel alignment for the Natal Care LX Incubators at their facility per attached Inspection Instructions for Assessing the Natal Care LX Wheeled-Based Joint and Weld. Customers are provided with the Natal Care LX Rolling Base Verification Form (DOC-019727) and are requested to verify the weld and gap status for each of the four wheels on the incubator and to note the results on the verification form. After the Verification form is completed and returned to Natus, Natus will arrange to ship a repair kit for each affected wheel, along with instructions and simple tools to facilitate the repair of the Natal Care LX base. Natus Technical Service will follow-up with phone calls to all non-responding customers and again to verify that the repairs have been performed. Consignees who have any questions, please call Technical Service at 888-496-2887 or send email to technical_service@natus.com

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

FMZ

Quantity affected

104 units

Distribution

US Distribution to the states of : AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC and VA, and Internationally to Pakistan.

Date initiated

2016-08-25

Date posted

2016-10-07

Date terminated

2017-03-07

Location

Seattle, WA

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