Events

Alerta De Seguridad para 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).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH; Siemens Healthcare GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1842
  • Fecha
    2016-03-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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."
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA