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Recall Observatory FDA recall evidence

Device product

The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.

Z-0056-2017

August 25, 2016

Class II

Product summary

Firm
Natus Medical Incorporated
Event
Event 74627
Status
Terminated
Classification
Class II
Quantity
104 units
Official record key
device-enforcement:Z-0056-2017

Official wording

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.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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