Events

Rappel de Scanpoint Communication Cradles

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 Verathon, 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
    56790
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0143-2011
  • Date de mise en oeuvre de l'événement
    2010-09-20
  • Date de publication de l'événement
    2010-10-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94510
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Cause
    Incorrect programming causes quickprint to fail to recognize the communication cradles. as a result, scanpoint communications cradles could not communicate with scanpoint online tool while using the quickprint interface. this will affect the transfer of exams and device calibration through quickprint interface.
  • Action
    On 09/20/10, Verathon issued an URGENT: Medical Device Accessory Recall Notification letter dated September 20, 2010 to consignees, identifying the affected product, the issue prompting the recall, and actions to be taken by consignees. The consignees are instructed to return any cradles within the serial number range between CC012000-CC012084, and the Part Number 0570-0168. The firm will provide a replacement communication cradle at no cost. Consignees can contact Verathon Customer Care at 425-867-1348 or 800-2331-2313 or send e-mail to cservice@verathon.com.

Device

Scanpoint Communication Cradles
  • Modèle / numéro de série
    Serial numbers:  CC012000, CC012001, CC012002, CC012003, CC012004, CC012005, CC012006, CC012007, CC012008, CC012009, CC012010, CC012011, CC012012, CC012013, CC012014, CC012016, CC012017, CC012018, CC012019, CC012020, CC012021, CC012022, CC012024, CC012026, CC012027, CC012028, CC012029, CC012030, CC012031, CC012032, CC012033, CC012034, CC012035, CC012036, CC012037, CC012038, CC012039, CC012040, CC012041, CC012042, CC012044, CC012045, CC012046, CC012049, CC012050, CC012052, CC012054, CC012055, CC012056, CC012057, CC012058, CC012059, CC012060, CC012061, CC012062, CC012063, CC012064, CC012065, CC012066, CC012067, CC012068, CC012069, CC012070, CC012071, CC012072, CC012075, CC012076, CC012080, CC012083, and CC012084.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: U.S. nationwide including states AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, ND, NY, OH, PA, SC, TN, TX, UT, WI, and Washington DC, and the countries of Australia, Canada, France, South Korea, Taiwan, The Netherlands, and United Kingdom.
  • Description du dispositif
    The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA