Events

Rappel de Device Recall Performa TM300 Traction 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 Sammons Preston Rolyan, An Ability One Company.

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
    31492
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1444-05
  • Date de mise en oeuvre de l'événement
    2005-07-13
  • Date de publication de l'événement
    2005-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-01-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37983
  • 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
    Apparatus, Traction, Non-Powered - Product Code HST
  • Cause
    The traction device may malfunction, producing oscillation and a jerking motion.
  • Action
    Sammons Preston Roylan, the U.S. agent for Ito Co., Ltd. issued recall letters dated 7/13/05 to all of their customers who purchased the Performa TM-300 traction unit, informing them that the manufacturer, Ito Co., Ltd., is recalling the units because the units may exhibit oscillation during some traction modes. The accounts were requested to contact Tina Kreisher at 1-800-323-5547, ext. 1383 if their TM-300 unit has a serial number that falls in the range listed in the recall letter. Tina will arrange for the unit to be shipped to the manufacturer's authorized repair center for upgrading of the software to version 2.8, and for the shipment of a loaner unit while their unit is being upgraded.

Device

Device Recall Performa TM300 Traction System
  • Modèle / numéro de série
    Product No. A501-009, serial numbers 1000 through 1207
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Canada, the United Kingdom, Korea, Turkey and Indonesia
  • Description du dispositif
    TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan
  • Manufacturer
    Sammons Preston Rolyan, An Ability One Company

Manufacturer

Sammons Preston Rolyan, An Ability One Company
  • Adresse du fabricant
    Sammons Preston Rolyan, An Ability One Company, 4 Sammons Ct, Bolingbrook IL 60440-4995
  • Source
    USFDA