Medical device recalls Moderate risk

Natus Medical Incorporated recalls The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0…

Recall date
August 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0056-2017
FDA classification
Class II
Brand / firm
Natus Medical Incorporated
Sold / distributed
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.

Why it was recalled

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.

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

What was recalled

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

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