Events

Alerte De Sécurité sur LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884, 3100035 to 3100058 and 3100065 to 3100145

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 VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation.

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
    1551
  • Date
    2015-03-11
  • 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 clarifies that the use of the affected equipment may cause the procedure to be suspended due to the shutdown defect mode of the monitor, requiring an alternative technique during the procedure if the monitor turns off and does not allow viewing.
  • Cause
    Vr medical informs that, through a statement issued by sony brazil, it was informed of the need to replace the power plate of the anvisa 80102510940 lcd monitors. this need arises from the fact that the monitors do not turn on or lose the image during the clinical use. according to manufacturer's investigation the problem is due to a disconnection of the internal power supply caused by failure in the integrated circuit of the power board. it was reported that up to now in brazil there have been no reports of adverse events associated with this mode of defect.
  • Action
    The company directs users who own affected equipment to follow the guidelines outlined in the SONY Communiqué: 1) If you have an AC adapter (AC-110MD) for each of your affected monitors, only use the AC adapter when the monitors are in use; 2) If you do NOT have an AC adapter (AC-110MD) for each of the affected monitors, stop using the operation monitor until the permanent corrective measure is deployed. For more information, access the appendix Customer Information - Sony LCD Monitor

Device

LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884,...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation
  • Source
    ANVSANVISA