Events

Safety Alert for LCD MONITOR SONY, Model LMD-1951 MD Registration 80102510940, Serial numbers: 3000038 to 3004884, 3100035 to 3100058 and 3100065 to 3100145

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; Sony Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1551
  • Date
    2015-03-11
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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