Events

Rappel de Device Recall Carestream Touch Prime

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 Carestream Health Inc.

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
    74652
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2217-2016
  • Date de mise en oeuvre de l'événement
    2016-07-08
  • Date de publication de l'événement
    2016-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148112
  • 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
    A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. for example, measurement results of the anatomy may appear enlarged or distended when it actually is not.
  • Action
    The firm, Carestream Health Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter dated 7/7/2016 and response form the end users/customers on 7/8/2016 via Certified Mail, Return Receipt Requested. The letter described the product, problem and actions to be taken. The Customers were instructed not use the generic volume measurement tool until Carestream has updated the system software. In the interim, calculate volumes by using the specific volume tool from the desired calculation package. If you have distributed the device outside your facility, please alert your customer(s) of this field correction and contact Carestream Customer Care Center as listed above. Carestream has created a software update for Touch Ultrasound to resolve this issue and will update your software. Carestreams representative will contact you and schedule a convenient time to upgrade the software. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910 (available on a 24/7 basis). Outside of the US, please call your local Service support number.

Device

Device Recall Carestream Touch Prime
  • Modèle / numéro de série
    Touch Prime Serial Numbers: 1037, 1038; -- Touch Prime XE Serial Numbers: 1021, 1079, 1067, 1041, 1043
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US Distribution to states of: GA, IA, and TX; and country of: Italy.
  • Description du dispositif
    Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound || Diagnostic ultrasound imaging or fluid flow analysis of the human body
  • Manufacturer
    Carestream Health Inc

Manufacturer

Carestream Health Inc
  • Adresse du fabricant
    Carestream Health Inc, 150 Verona St, Rochester NY 14608-1733
  • Société-mère du fabricant (2017)
    ONEX Corp
  • Source
    USFDA