Events

Recall of Device Recall Medix NatalCare STLX Intensive Care Incubator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72894
  • Event Risk Class
    Class 2
  • Event Number
    Z-1363-2016
  • Event Initiated Date
    2016-01-08
  • Event Date Posted
    2016-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142443
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Incubator, neonatal - Product Code FMZ
  • 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.
  • Action
    Natus of Seattle, WA began sending the Urgent Field Safety Notice NatalCare LX Incubator letter (DOC-017939A) to consignees on 1/8/16. A repair kit to correct this issue is now available for repair of affected units. Consignees should complete the NatalCare LX Incubator Oval Port Hinge Repair Kit Order Form and FAX it 847-949-6031 or scan and email this form to Natus_Quality_Programs@natus.com. Alternately you can telephone Natus Technical Service at 888-496-2887 and order the kit from a specialist. Natus will send the kit(s) free-of-charge to the address you specify. Each upgrade will require up to ¿ - 1 hour of time and require simple hand tools. If you have any questions, please contact Technical Service at 888-496-2887 or send email to: customer.service@natus.com

Device

Device Recall Medix NatalCare STLX Intensive Care Incubator
  • Model / Serial
    Serial numbers:  5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5294; 5293; 5292; 5291; 5290; 5289; 5287; 5283; 5282; 5281; 5280; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; 5129; 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; 5045.  Serial numbers were updated in the final status report. They are as follows: 5552; 5551; 5550; 5549; 5510; 5509; 5508;5507; 5506; 5505; 5504; 5389; 5388; 5385; 5383; 5337; 5336; 5335; 5334; 5333; 5332; 5331; 5330; 5329; 5328; 5327; 5326; 5325; 5324; 5323; 5322; 5294; 5293; 5292; 5291; 5290; 5289; 5288; 5287; 5286; 5285; 5284; 5283; 5282; 5281; 5280; 5279; 5278; 5277; 5276; 5257; 5256; 5255; 5254; 5253; 5252; 5251; 5250; 5249; 5248; 5228; 5227; 5226; 5225; 5224; 5223; 5222; 5221; 5220; 5219; 5214; 5213; 5212; 5211; 5210; 5209; 5139; 5138; 5136; 5135; 5134; 5133; 5132; 5131; 5130; and 5129.  The following serial numbers were removed: 5097; 5096; 5057; 5056; 5053; 5051; 5048; 5047; 5046; and 5045.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide and Pakistan.
  • Product Description
    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Manufacturer Address
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA