Events

Rappel de iLab Ultrasound Imaging System

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 Boston Scientific Corporation.

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
    67959
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1487-2014
  • Date de mise en oeuvre de l'événement
    2014-04-03
  • Date de publication de l'événement
    2014-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126666
  • 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
    System, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    Specific ilab ultrasound imaging systems using newest 3.0 (polaris 1.0) software change the pullback speed from the default setting of 0.5 mm/sec to 1.0 mm/sec, the longview distance measurement may display an inaccurate value that is double the actual distance.
  • Action
    Boston Scientific sent an Urgent Medical Device Field Correction letter to all affected customers via hand delivery by BSC sales representatives. The letter identifed the affected product, problem and actions to be taken. Customers were asked to immediately post the Field Correction information in a visible location near the system(s) to ensure it is easily accessible to all users of the device. For question contact your local Sales Representative.

Device

iLab Ultrasound Imaging System
  • Modèle / numéro de série
    Model Numbers: H749ILAB120CART0 H749ILAB120INS0 H749ILAB120N2710 Serial numbers: 4219, 4900, 5701, 5827 7516, 7517, 7607 8407, 8434. the different UPNs represent minor level differences in configuration relative to mobility and no difference in any essential components or software.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the states of NY, NC, DC, FL, PA
  • Description du dispositif
    iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Adresse du fabricant
    Boston Scientific Corporation, 47215 Lakeview Blvd, Fremont CA 94538-6530
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA