Events

Alerte De Sécurité sur Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affected model (s); and Lot (s) / Serial number (s) affected: OPTIMA XR220AMX ... The Optima XR200amx and BRIVO XR285amx X-ray systems (ANVISA Registration 80071260246) are also affected.

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 GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil.

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
    1785
  • Date
    2015-01-05
  • 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
    Dropping the arm assembly can result in personal injury to a person. To date, there have been no incidents or injuries reported as a result of this security problem found internally. ### Field Action Update: UPDATED ON 10/23/2017, the company filed the field action completion report verifying the sending the security warning to the client with evidence of science and all actions completed.
  • Cause
    Problem related to the operation of the safety lock of the column that supports the horizontal arm. this safety latch mechanism acts as backup in the unlikely event of the primary safety cable breaking.
  • Action
    CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. / / Field Action: Field Correction - Parts / Parts Correction. /// Field Action Code: IMF 10906./// The system may continue to be used. A GE Healthcare representative will contact the establishments that have equipment affected by this field action to arrange for correction.

Device

Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affe...

Manufacturer

GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil