Events

Alerte De Sécurité sur DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121 / SN09000086, 426122 / SN09000092, 456396 / SN10000277, 483715 / SN11000504, 512026 / SN12000272, 514483 / SN13000004, 521862 / SN13000033

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 Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH.

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
    1502
  • Date
    2014-11-05
  • 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 makes it clear that if the hook does not securely support the feet in an upright position, the support may fall and injure the operator or patient. #### UPDATED 7/18/2017, the company submitted field action proving the replacement of the part as planned.
  • Cause
    The platform for the entire column exams can be fixed in the upper position. when the clamp (hook) is not adjusted in its correct position, the foot support is not secured securely. if it falls, it may hurt the operator's or patient's foot (for example, when moving the stand or when the operator can not fix it correctly when moving the stand up). the following factors are necessary for this situation to occur: - hook not properly adjusted - operator does not recognize that the hook is not engaged in the correct place - patient support is moved (rotated) - hook is not secure - foot is in "risk area".
  • Action
    The customer / user should always check the correct hook position and whether the hook is locked. (Press the hook down until it locks in place) Ensure that the hook is in the position shown in the figure with the green arrow (at the safety warning).

Device

DigitalDiagnost Radiology System - Registration No. 10216710214, Serial Numbers: 13000321, 426121...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems DMC GmbH
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA