Natus Medical Incorporated recalls Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

Recall date

January 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1363-2016

FDA classification

Class II

Brand / firm

Natus Medical Incorporated

Sold / distributed

Distribution US nationwide and Pakistan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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