Events

Recall of Device Recall The Medix NatalCare STLX Intensive Care Incubator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74627
  • Event Risk Class
    Class 2
  • Event Number
    Z-0056-2017
  • Event Initiated Date
    2016-08-25
  • Event Date Posted
    2016-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Incubator, neonatal - Product Code FMZ
  • Reason
    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
    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

Device

Device Recall The Medix NatalCare STLX Intensive Care Incubator
  • Model / Serial
    5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221, 5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288, 5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325, 5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335, 5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507, 5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548, 5549, 5550, 5551, and 5552.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. || Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Manufacturer Address
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA