Events

Rappel de Device Recall Siemens mMLC (ModuLeaf)

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 Siemens Medical Solutions USA, 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
    61237
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1184-2012
  • Date de mise en oeuvre de l'événement
    2012-02-07
  • Date de publication de l'événement
    2012-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107631
  • 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
    Block, beam-shaping, radiation therapy - Product Code IXI
  • Cause
    This correction is being performed to update the safety knob of the siemens brand mmlc (moduleaf) to conform to tie iec 60601-1 safety standard.
  • Action
    The firm, SIEMENS, issued a "Customer Information" letter to its customers. The letter described the product, problem and actions to be taken. Siemens developed a new steel knob that complies with the latest standards; Siemens checked all ModuLeaf mMLC trolleys and if necessary refitted with the safety label and also arranged for an inspection and modification of the customers system- a Release of the safety update UI TH 026/11/S to distribute and hardware update commenced on February 7, 2007 by certified mail. If you have any questions, contact the Regulatory Specialist II at 925-602-8175.

Device

Device Recall Siemens mMLC (ModuLeaf)
  • Modèle / numéro de série
    ModuLeaf, 110V/60Hz, part number 7334043; ModuLeaf, 220V/60Hz, part number 7334050.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CO, IA, KY, NJ, OH and TX; and countries of: Algeria, Austria, Belgium, Brazil, China, Egypt, France, Germany, Hungary, India, Italy, Japan, Kuwait, Malaysia, Mexico, P.R., Russian Fed., Saudi Arabia, South Africa, Spain, Turkey, and United Kingdom.
  • Description du dispositif
    Siemens mMLC (ModuLeaf) safety bar and trolley label. || Siemens Medical Solutions USA, Inc. || Concord, CA. || The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA