Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1363-2016 — Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.

U.S. FDA — Device Enforcement · United States · 2016-01-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1363-2016
Date of alert
2016-01-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Natus Medical Incorporated
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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