Events

Safety Alert for ARTIS EQUIPMENT FOR ANGIOGRAPHY. ANVISA Registry No. 10345162023. Risk class III. Serial numbers: 154646 (Artis zee biplane); 147531, 147551, 147582, 147600, 147602, 147617, 147619, 147637, 147650, 147706, 147708, 147819, 147826 (Artis zee ceiling); 139013, 137013, 136918, 136933, 136936, 136944, 136947, 136977, 136995, 137020, 137026, 137033, 137042, 137045, 137074, 137083, 137088, 137089, 137090, 137094, 137098, 137099, 137100, 137102, 137143, 137159, 137162, 137161, 137162, 137164, 137182, 137191, 137246, 137281, 137299, 137300, 137310, 137324, 137346, 137379, 137382, 137387, 137411, 137416, 137426, 137436, 137447, 137624, 137658 (Artis zee floor); 160143, 160457, 160836, 160843, 160946, 160976 (Artis zeego).

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 AG; Siemens Healthcare GmbH; 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
    1842
  • Date
    2016-03-30
  • 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 "Recommends users of the target devices of this field action to wait until the Siemens engineering team schedules a field visit so that the problem is definitely corrected."
  • Reason
    Siemens healthcare informs that field action ax075 / 15 / s & ax076 / 15 / s addresses two possible mutually independent causes of a system defect. a) in artis zeego systems, angles around the collision area of ​​arm c can obstruct cable entry, resulting in mechanical damage. b) in artis systems with a100plus generators, an attempt to resume operation after detecting a fault (such as a short-circuit in the x-ray light bulb) may cause a module failure in the high-voltage generator.
  • Action
    The field action code AX075 / 15 / S & AX076 / 15 / S initiated by Siemens deals with a field correction, software update, by prior letter of the client, with risk classification III (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences). Recommendation to Users and Patients: We recommend that users of the target devices of this field action wait until the Siemens engineering team schedules a field visit so that the problem is finally corrected.

Device

ARTIS EQUIPMENT FOR ANGIOGRAPHY. ANVISA Registry No. 10345162023. Risk class III. Serial numbers:...

Manufacturer

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