Events

Rappel de Device Recall CIVCO General Purpose Sensor

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 Civco Medical Instruments 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
    61793
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1953-2012
  • Date de mise en oeuvre de l'événement
    2012-05-07
  • Date de publication de l'événement
    2012-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109098
  • 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 echo, ultrasonic - Product Code IYO
  • Cause
    The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
  • Action
    CIVCO sent an Urgent Medical Device Recall letter dated May 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return all general purpose sensors as the product may not function as intended. To return the affected product customers should contact the OEM Sales Coordinator at 319-248-6521 to schedule the return of their device. Upon receipt of the snesor, CIVCO will arrange for recalibration. Once recalibration is completed, the sensor will be returned to the customer at no charge. Customers were asked to forward this communication to all their customers who purchased the affected product. Once CIVCO has received the customer list, they will contact the end-user to request they return their general purpose sensor directly to CIVCO for recalibration. For questions customers should call 800-441-6741. For questions regarding this recall call 319-656-4447.

Device

Device Recall CIVCO General Purpose Sensor
  • Modèle / numéro de série
    Lot numbers M867430 and M873080
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
  • Description du dispositif
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. || The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
  • Manufacturer
    Civco Medical Instruments Inc

Manufacturer

Civco Medical Instruments Inc
  • Adresse du fabricant
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA