Events

Rappel de CIVCO Arm Support

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 Med Tec 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
    77874
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3083-2017
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158116
  • 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
    Cradle, patient, radiologic - Product Code KXH
  • Cause
    Rigid arm supports (pn: 106015 and 106047), which were used as part of the posiboard-2 and posirest, and were distributed as pn: 106015, 106047, 106521, 106522, 109030, and 109040 between ocotober 2009 and july 2012 may have a height difference of approximately 17mm.
  • Action
    CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 between 8:00AM and 5:00PM CST. For further question, please call (319) 248-6537.

Device

CIVCO Arm Support
  • Modèle / numéro de série
    Codes: M181690, M194500, M203470, M213330, M216050, M142180, M143110, M149600, 0154710, M158550, M165330, M16900, M169330, M142230, M149650, M236810
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
  • Description du dispositif
    CIVCO Arm Support, REF 106047, distributed as: || (a) Rigid Arm Support, Large, Set, Red (PN: 106047) || (b) PB2-BDLRL (PN: 109040) || (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) || (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) || The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
  • Manufacturer
    Med Tec Inc

Manufacturer

Med Tec Inc
  • Adresse du fabricant
    Med Tec Inc, PO Box 320, 1401 8th St SE, Orange City IA 51041-7463
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA