Safety Alert for Trade name: APTIO AUTOMATION. ANVISA registration number: 10345161904. Hazard class: I. Affected serial numbers: APT.0154.12.14; APT.0133.09.14; APT.0179.02.15; APT.0209.04.15; APT.0266.10.15

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 Diagnostics 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
    1930
  • Date
    2016-06-16
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    Recommendation to users and patients: Siemens HealthCare Diagnostics suggests that the instructions provided by the Hettich company be followed. Siemens Healthcare Diagnostics strongly recommends that centrifuge maintenance be performed according to the instructions described in the User's Guide and at the indicated intervals. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    The field action lai 16-02 refers to the supports that are used in the hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges centrifuges. there may be faulty support during the procedure, such as moving or rotating the centrifuge.
  • Action
    The field action code LAI 16-02 initiated by Siemens deals with the sending of a Letter to the Customer - Safety Alert Recommendation to users and patients: Siemens HealthCare Diagnostics suggests that the instructions provided by the company Hettich be followed. Siemens Healthcare Diagnostics strongly recommends that centrifuge maintenance be performed according to the instructions described in the User's Guide and at the indicated intervals.

Manufacturer