Recall Z-1363-2016— Natus Medical Incorporated

Name: FDA recall Z-1363-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-08

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2016-01-08, terminated 2017-02-10. It names one FDA 510(k) clearance: K070291. Product: Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.. Reason: 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..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Terminated: 2017-02-10
Firm location: Seattle, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BXMedix I.C.S.A.·cleared 2007-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.