Events

Safety Alert for FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF, Registry No. 10234230153. Series numbers affected in Brazil: 1163; 1280; 1287; 1300; 1302; 1303; 1308; 1310; 1311; 2053; 2179; 2181; 2270; 2307; 2308.

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

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
    1730
  • Date
    2015-11-04
  • 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 using the automatic exposure control, the maximum exposure time is usually limited to 500 ms. Therefore, this will be the maximum time a patient can be exposed to unintentional radiation. In addition, overexposure of image may occur and thus does not provide good diagnostic quality.
  • Reason
    Siemens healthcare has identified that during an rad examination with automatic exposure control, an unexpected malfunction may result in a longer radiation exposure than is required. this can also result in overexposure of image and not provide good diagnostic quality. as a result, the examination performed will need to be repeated. this malfunction can only occur in auto exposure mode.
  • Action
    Siemens Healthcare informs that no action can be taken to prevent such malfunction. However, it does not recommend discontinuation of equipment use. Once all necessary material is available for the software update, it is recommended that the identified customers immediately accept the appointment of a Siemens technician visit, so as not to delay the correction that will be carried out in the field.

Device

FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF, Registry No. 10234230153. Series numbers affecte...

Manufacturer

Siemens Ltda.; Siemens AG
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA