FDA-Device2016-04-20Class II

Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

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.

Sold states
Distribution US nationwide and Pakistan.
Affected count
75 units (65 units in the US and 10 units in Pakistan) updated in final status report 36 customers with 96 units.
Manufactured in
5900 1st Ave S, N/A, Seattle, WA, United States
Products
Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1363-2016

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