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Natus Medical Incorporated recalls Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Recalled April 20, 2016 · FDA recall Z-1363-2016 · Natus Medical Incorporated
Hazard
NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator. · FDA Class II
Units
75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.
Sold at
Distribution US nationwide and Pakistan.
Description
NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose and possibly result in the port detaching from the incubator.
Product
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Manufacturer(s)
Natus Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →