Events

Rappel de Device Recall Jupiter, Mars, Titan, TruSystem and Saturn operating table systems

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 Trumpf Medical Systems, 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
    73103
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0759-2016
  • Date de mise en oeuvre de l'événement
    2016-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143071
  • 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, surgical with orthopedic accessories, ac-powered - Product Code JEA
  • Cause
    Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum trendelenburg position.
  • Action
    TRUMPF Medical sent an Urgent Field Safety Information letter dated January 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed to take the following actions: Actions to be taken 1. Remove the patient transport Shuttle from operation. 2. Trumpf Medical, or a designated service representative, will schedule an appointment with the customer to perform service on the impacted device to prevent the issue from occurring. Passing along this information: Please make sure that, in your organization, all users of the patient transport Shuttle as well as any other personnel who must be informed, have been made aware of this safety information. If you have provided the device to third parties, please forward them a copy of this letter, or inform the contact person listed above. Please store this information at least until this measure has been completed. If you have any questions concerning this request or the procedure as outlined, please contact Trumpf Medical Systems, Inc. at 888-474-9359 For questions regarding this recall call 843-534-0606.

Device

Device Recall Jupiter, Mars, Titan, TruSystem and Saturn operating table systems
  • Modèle / numéro de série
    Product: Shuttle 2.7, Material Number: 1254362, Serial Number Range: 100801175  101349420; Product: Shuttle 2.7 360, Material Number: 1459862, Serial Number Range: 100843669-101212847; Product: Shuttle 3.7, Material Number: 1254363, Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360, Material Number: 1459863, Serial Number Range: 100787418-101334652.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
  • Description du dispositif
    Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). || The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Adresse du fabricant
    Trumpf Medical Systems, Inc., 1046 Legrand Blvd, Charleston SC 29492-7672
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA