Events

Rappel de Device Recall Capintec Captus 3000 Thyroid Uptake 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 Capintec 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
    62982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2312-2012
  • Date de mise en oeuvre de l'événement
    2012-07-24
  • Date de publication de l'événement
    2012-09-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112193
  • 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
    Probe, uptake, nuclear - Product Code IZD
  • Cause
    Customers who received a capintec captus 3000 thyroid uptake system with software revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?measure liquid and subtract residual." this protocol was a new feature added to software revision 1.22 in january 2011. the error occurs only if the user does not measure the residual dose immediately after me.
  • Action
    The firm, CAPINTEC, INC., sent a "SOFTWARE ERROR ALERT" letter dated July 20, 2012 to all affected consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the four measuring steps outlined in the letter; DO NOT PRINT, EXIT THE THYROID UPTAKE MODULE, OR MEASURE ANOTHER PATIENT BEFORE YOU HAVE COMPLETED THESE FOUR MEASUREMENT STEPS; and follow the attached addendum for step-by step instructions. Capintec will send corrected software to all affected customers in approximately 2-3 weeks. The customers are instructed to contact Capintec Customer Support Representative if you have any questions or concerns regarding this notification, or if you do not receive your replacement software. Capintec Customer Support can be reached by phone at 1-800-631-3826 or by email at getinfo@capintec.com or by visiting our website at www.capintec.com.

Device

Device Recall Capintec Captus 3000 Thyroid Uptake System
  • Modèle / numéro de série
    Catalog numbers for new systems: 5430-0076, 5430-0077, 5430-0103, and 5430-0087. Catalog numbers for conversion systems: 5430-0118 and 5430-0119. Serial numbers for new systems: 901006 through 901394, inclusive. Serial numbers for conversion systems: CNV 674 through CNV 730, inclusive. Also affected are devices which were serviced and devices for which customers received software upgrades between January 20, 2011 and June 30, 2012 with Revision 1.22, 1.23, 1.24, 1.25, or 1.26. (NOTE: Item number 5430-0075, Captus 3000 well counter system, is excluded. This system does not have the ability to perform thyroid uptake procedures.)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Belgium, Brazil, Canada, China, Greece, Hong Kong, India, Israel, Malaysia, Philippines, Spain, South Korea, Thailand, and Turkey.
  • Description du dispositif
    Capintec Captus 3000 Thyroid Uptake System || Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
  • Manufacturer
    Capintec Inc

Manufacturer

Capintec Inc