Events

Alerte De Sécurité sur CENTRIFUGAL COMBAT (ANVISA Registry No. 80197039011), affected batches: 100804 and 110115 (series: from 6334 to 6391), affected batches: 100804 and 110115 (series: from 6334 to 6391) .

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 CELM CIA EQUIPADORA DE LABORATORIOS MODERNOS.

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
    1128
  • Date
    2012-05-02
  • 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
    According to the company, the field action was initiated in view of a complaint from a customer, who noticed that the engine of the equipment was slack, produced unusual noise and stopped suddenly during use. After a root-cause analysis, it was detected that the motor support was broken and that it had small cracks, possibly due to inadequate design of the motor base. The company made improvements in the part and validated the new project, through tests of operation under extreme conditions of use. #### Update (10/26/2012): The company reported having terminated the corrective action on August 23, 2012, correcting 96 equipment (out of a total of 108 units).
  • Cause
    Possibility of breaking the motor base of the centrifuge.
  • Action
    The company initiated the corrective action and informed UTVIG that it had already sent replacement parts to 80% of the affected products. If your Health Center has product (s) affected by this field action and has not yet been contacted by CELM Authorized Technical Assistance, you must notify the company to arrange for the correction of your health condition (s) equipment - see address, telephone and company email in the Manufacturer's Description field.

Device

CENTRIFUGAL COMBAT (ANVISA Registry No. 80197039011), affected batches: 100804 and 110115 (series...

Manufacturer

CELM CIA EQUIPADORA DE LABORATORIOS MODERNOS
  • Source
    ANVSANVISA