The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
Recall
- Recall Number
- Z-0056-2017
- Event Number
- 74627
- Firm
- Natus Medical Incorporated
- FEI Number
- 3018859
- Product Code
- FMZ
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- August 25, 2016
- Posted
- October 7, 2016
- Terminated
- March 7, 2017
- Address
- 5900 1st Ave S, Seattle, WA, 98108-3248
Description
The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
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.
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 [email protected]
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.
104 units