Z-0056-2017Class II

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

Name: Z-0056-2017 The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003...
Creator: Natus Medical Incorporated
Published: 2016-08-25
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2016-08-25 / Terminated / root cause: manufacturing process

FDA source

Natus Medical Incorporated began a recall of The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007 on 2016-08-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0056-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-10-07
Terminated: 2017-03-07
Recalling firm: Natus Medical Incorporated
Product: The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0056-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0056-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-07

Product code FMZ

K070291Class IIMedix Natal Care Intensive Care Incubator, Models-Natal Care St-Mx/lx/bxMedix I.C.S.A. / cleared 2007-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)