Events

Alerte De Sécurité sur COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM EMOTION MARK SIEMENS, Registry No. 10234230121; COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM SPIRIT MARK SIEMENS, Registry No. 10234230116. Distribution_Number of Series of Equipment - See Annex I.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1382
  • Date
    2014-05-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The company informs that very rarely the rubber damper can break and cause detachment of the mounting plates in the gantry and can lead to a rupture of the drive belt, and consequently the interruption of image acquisition. In addition, the drive belt can damage the system cover and may invalidate contact protection between moving components inside the gantry and the operator and / or patient.
  • Cause
    The company recently detected the possibility of a premature aging process in a rubber component. the mechanical operation of this rubber damper, which is located in the rotating motor assembly, may degrade over time and impact the stability of the equipment.
  • Action
    Siemens has prepared a modification for SOMATOM Emotion 6/16, and for SOMATOM Spirit / Spirit Power that will solve this potential breakdown through UI CT030 / 14 / S. The CT030 / 14 / S IU implementation is scheduled for April 2014 and your corrective action instructs our service specialists to replace the rotating motor mounting plate inside the gantry of your CT system by a new model. This new mounting plate includes significantly improved rubber dampers for the stability of your mounting set. The company will schedule customers. See Letter to the Client - Annex II

Device

COMPUTERIZED TOMOGRAPHY EQUIPMENT SOMATOM EMOTION MARK SIEMENS, Registry No. 10234230121; COMPUTE...

Manufacturer

Siemens Ltda
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA