Events

Safety Alert for CLINICAL CHEMISTRY SYSTEM DIMENSION RXL MAX - Registration nº 10345161632. Serial Numbers: Annex I - Distribution Map

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 Diagnóstics 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
    1762
  • Date
    2015-12-01
  • 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 informs that the absence of the safety cover can cause a risk of electric shock to the operator. This question does not affect patient outcomes.
  • Reason
    Siemens healthcare has identified that in some rms refrigeration compressors, safety cover may be missing, in the electrical termination block. exposure to electrical risk in the electrical termination block is located immediately behind the rms waste container.
  • Action
    Care should be taken when removing the waste container from the RMS module. Under no circumstances should you place your hands in the RMS cabinet beyond what is necessary to remove the waste container. If any flex cartridge drops out of the waste container, do not enter the RMS cabinet to remove it. In addition, the WARNING page posted within the Warning Message should be attached on the outside of each RMS cabinet the customer owns, serving as a temporary warning to all operators until the machines are inspected. Please note that only customers who own the RMS module (optional) will be subject to the field action (Code DI 16-01)

Device

CLINICAL CHEMISTRY SYSTEM DIMENSION RXL MAX - Registration nº 10345161632. Serial Numbers: Annex ...

Manufacturer

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