Events

Alerte De Sécurité sur 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).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A; Siemens AG; Siemens Healthcare GmbH; Siemens Healthcare GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1842
  • Date
    2016-03-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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."
  • Cause
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA