Events

Rappel de TruSystem

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
    66688
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0342-2014
  • Date de mise en oeuvre de l'événement
    2013-10-28
  • Date de publication de l'événement
    2013-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122967
  • 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, manual - Product Code JEB
  • Cause
    The coupler point (hood) of the leg section one part light may become detached from the leg section frame.
  • Action
    TRUMPF sent an Urgent Safety Information letter dated October 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to inspect Leg Section One Part Light for damage to the coupler point (hook) between each case. If any damage is noticed to the coupler, they were instructed to stop use immediately and contact TRUMPF Technical Service. If they drop or collide the Leg Section One Part Light into anything then stop use immediately and contact TRUMPF Technical Service. Review the User Instruction for proper use and care of the device. The leg section should be used only as intended as part of the TRUMPF TS7000 surgical table. The intended use is to support and position the patients legs during the pre-operative and post-operative stages of surgery. The leg section should be removed during surgery. TRUMPF will be exchanging the hooks, counter plates and screws of the coupler point to increase the area that the load is distributed over. This will allow the screws securing the hood to the leg frame to withstand external forces. TRUMPF anticipates parts to be available the first week of November. TRUMPF trained technicians will complete the TRUMPF Medical Systems, Inc. for the part exchange. Completion is anticipated by November 11, 2013. Further questions please call (843) 534-0606

Device

TruSystem
  • Modèle / numéro de série
    Item no. 1739993, All serial numbers.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.
  • Description du dispositif
    TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU || Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.
  • Manufacturer
    Trumpf Medical Systems, Inc.

Manufacturer

Trumpf Medical Systems, Inc.
  • Adresse du fabricant
    Trumpf Medical Systems, Inc., 415 Jessen Ln, Charleston SC 29492-7906
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA