Recall Z-0056-2017— Natus Medical Incorporated

Name: FDA recall Z-0056-2017
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Class II · Terminated

Class II FDA medical device recall by Natus Medical Incorporated, initiated 2016-08-25, terminated 2017-03-07. It names one FDA 510(k) clearance: K070291. Product: The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.. Reason: 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..

Recalling firm: Natus Medical Incorporated
Classification: Class II
Status: Terminated
Initiated: 2016-08-25
Terminated: 2017-03-07
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

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

Reason for recall

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.

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