Events

Safety Alert for ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 10345162023 Hazard Class: III Model Affected: Artis zee ceiling Serial Numbers Affected: 17582

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 GmbH.

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
    2241
  • Date
    2017-03-20
  • 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
    Siemens recommends the use of sterilized covers to protect the wireless radar drive pedal from all types of contamination. Since it is already standard practice in many installations, this approach is an effective way to prevent the wireless radius trigger pedal from coming into contact with liquids. When cleaning or disinfecting the radiation trigger pedal, use cloths that are moist but not dripping. You should avoid immersing the wireless radiation trigger pedal into liquids until corrective action has been taken. If the wireless radiation trigger pedal stops working, the radiation delivery for acquisition of images continues to be possible via the manual radiation trigger pedal. Normal emergency procedures should be implemented in case of system failure. Ensure that these processes are prepared in advance until our countermeasures have been implemented. There is no need to re-examine any patients. This is a possible hardware defect that has no influence on the treatment of patients. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Reason
    Siemens healthcare diagnostics informs its customers about a potential safety quality issue that affects the use of the wireless radar foot pedal in an artis system. slack in the wireless radar trigger pedal may result in fluid entering the interior. these liquids may include disinfecting or cleaning agents but also body fluids, and may, in rare instances, result in failure of the wireless radiation drive pedal. only the wireless radiation trigger pedals that have been shipped with artis systems after january 1, 2005 are affected.
  • Action
    Field Action Code AX063 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.

Device

ARTIS ANGIOGRAPHY EQUIPMENT Technical Name: Angiography Equipment ANVISA Registration Number: 103...

Manufacturer

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