Events

Rappel de Device Recall Medix NatalCare STLX Intensive Care Incubator

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Natus Medical Incorporated.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    72894
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1363-2016
  • Date de mise en oeuvre de l'événement
    2016-01-08
  • Date de publication de l'événement
    2016-04-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142443
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Incubator, neonatal - Product Code FMZ
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution US nationwide and Pakistan.
  • Description du dispositif
    Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
  • Manufacturer
    Natus Medical Incorporated

Manufacturer

Natus Medical Incorporated
  • Adresse du fabricant
    Natus Medical Incorporated, 5900 1st Ave S, Seattle WA 98108-3248
  • Société-mère du fabricant (2017)
    Natus Medical Incorporated
  • Source
    USFDA