Safety Alert for ARTIS EQUIPMENT FOR ANGIOGRAPHY. Anvisa Registry No. 10234230158. Affected Series: 10501, 25418, 35318, 35748, 35817, 35872, 35913, 135329, 135758, 135816, 135825, 135835, 135848, 135941, 136115, 136199, 136282, 136301, 136320, 136369, 136373 , 136419, 136908, 160143, 160360, 160415, 160457 and 160467.

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

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
    1202
  • Date
    2012-11-16
  • 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
    A certain component of the equipment - responsible for securing a pin to its original position - has not been adjusted correctly, which can cause the pin to come loose and leave some parts of the system loose, with the possibility of detaching. According to Siemens, the possibility of adverse events related to the operation of the system or the detachment and falling of parts, especially in the event of a collision with the equipment, can not be ruled out. The verification of the equipment has not yet been programmed by the company.
  • Reason
    No locking pin on the equipment, which can come out of position and let loose some parts of the system.
  • Action
    Siemens has already informed its customers of the problem and that a timeline for correction will be scheduled - the start date of the correction was not reported by the company.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA