Events

Rappel de Device Recall CIVCO ProLok Platform, REF MTSBRT002

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
    57543
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3019-2011
  • Date de mise en oeuvre de l'événement
    2010-12-30
  • Date de publication de l'événement
    2011-08-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96496
  • 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
    Table, radiographic, stationary top - Product Code IXQ
  • Cause
    Systems sold before december 2009 displayed a scale of 0-40cm going from left to right, while systems after december 2009 reversed this and were displayed as 40-0cm from left to right.
  • Action
    CIVCO issued a "FIELD SAFETY NOTIFICATION" letter dated 12/20/2010 beginning 12/30/2010, via FedEx or UPS to distributors and customers. The notification identifies the affected device, problem, and field safety corrective action. The letter states that if customers have more than one system purchased from different time periods that they should examine their systems and assess if there is any mismatch. The recalling firm will rework the system to correct the difference and send it back to the customer. To take advantage of this correction customers are advised to contact the recalling firm within thirty days of receiving the safety notification. The letter includes a response form to be completed and returned as per instructions, to indicate that the notice has been read and understood by all operators of the equipment. The letter to distributors requested that a copy of the notification letter be forward to all customers who have received this component. For assistance contact your CIVCO insides sales representative by calling CIVCO Medical Solutions, Radiation Oncology, at 800-842-8688.

Device

Device Recall CIVCO ProLok Platform, REF MTSBRT002
  • Modèle / numéro de série
    M074130, M092920, M115600, M143230, M165570, M188350, M191650, M207130, M208340, M213570, M218300, M230730, M248840, M248850 and M268010
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA ( nationwide) including the state of PA. and countries of: Canada, China, England, Israel, Italy, Japan, Korea, The Netherlands, Russia, Spain, Sweden, Switzerland and Turkey.
  • Description du dispositif
    CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa || Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic and other medical procedures.
  • 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