Events

Safety Alert for Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Model: H3 + (Plus - CHEXXXXX) /// Lots: 115190255741/115190255742/115190255743/115190255744/115190255744/115190255746 / 115190255759/115190255760/115190255761/115190255763/115190255764/115190255767/115190255769/115190255770/115190255773/115190255777/115190255778/115190255779/115190255780/115190255787/115190255788/115190255789/115190255786/115190255800/115190255803/115190255804/115190255808/115190255809/115190255810/115190255814/115190255822 / 115190255823/115190255824/115190255826/115190255827/115190255830/115190255832/115190255833/115190255834/115190255835/115260261298/115260261299/115260261300/115260261301/115260261302/115260261303/115260261304/115260261305/115260261306/115260261307/115260261308/115260261309/115260261310/115260261311/115260261312/115260261313 / 115260261314/115260261315/115260261316/115260261317/115260261318/11 52602613119/15260261320/115260261321/115260261322/115260261323/115260261324/115260261325/115260261326/115260261327/115260261328/115260261329/115260261330/115260261331/115260261332/115260261333/115260261334/115260261335/115260261336/115260261337/115260261338/115260261339/115260261340/115260261341/115260261342/115260261343 / 115260261344/115260261346/115260261348/115260261349/115260261350/115260261351/115260261351/115260261352/115260261353/115260261354/115260261355 115260261356/115260261357.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc..

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
    1862
  • Date
    2016-04-08
  • 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
  • Reason
    According to tkl, "we received a field corrective action notice from the manufacturer" field corrective action notice "on 11/19/2015, reporting that it identified a problem with the hardware of the h3 + model equipment, which could result in a battery current higher than normal and cause the device to record less time than expected, requiring corrective repair of the equipment hardware. ".
  • Action
    The action is being taken due to the identification of a problem in the hardware of the H3 + model, which can result in a higher than normal battery current and cause the device to record less time than expected, requiring corrective repair action device hardware. a) Risk classification III; b) Classification of the field action: Correction in Field / Correction of parts and pieces / Other situation (IncisoIV); c) Field action code: 001.16; d) recommendations to users and patients: Segregate product for service repair.

Device

Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Mo...

Manufacturer

TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc.
  • Source
    ANVSANVISA