Events

Safety Alert for Trade name: APTIO AUTOMATION; APTIO Automation Technical name: EQUIPMENT FOR PREPARING SAMPLES FOR IN VITRO DIAGNOSIS; Instrument exclusively intended for joining modules, integration of analyzers or test platforms. ANVISA Registration Number: 10345161904; 10345162051 Hazard Class: I Model Affected: Serial Numbers Affected: 808B-14-170; 808B-14-171; TSD-14-228; 808B-15-239; 808B-15-331; TSD-15-391; TSD-15-392

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare.

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
    2088
  • Date
    2016-10-28
  • 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 Siemens engineering team will visit the lab to exchange these power cables.
  • Reason
    Modules and their respective interface modules affected by this field action include a power cable that has two connectors that allow for two possible configurations. siemens healthcare diagnostics has been informed by our suppliers that the connector used to connect the modules to the power source of the automation system may overheat. the connector used to connect to a standard power source is not impacted by this problem.
  • Action
    Field Action Code LAI 16-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

Trade name: APTIO AUTOMATION; APTIO Automation Technical name: EQUIPMENT FOR PREPARING SAMPLES FO...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA