Events

Alerte De Sécurité sur Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class III, serial number of affected equipment and municipalities located: PADPVG01001 - SANTA ROSA; PADPXU01001 - FRUTAL ;. PADPVG02001 - CERES ;. PADPW801001 - LAGES ;. PADPVG03001 - TERESINA ;. PADQKC01001 - GOIANIA ;. PADQKC02001 - IMPERATRIZ ;. PADRNO02001 - JARU ;. PADRWY02001 - ARAPIRACA ;. PADRNO01001 - AMARANTE ;. PADRWY01001 - CAPANEMA ;. PACZUO01001 - CACOAL ;. PAD63801001 - GOIANIA; PADED101001 - RIO VERDE ;. PADKZ801001 - MONTENEGRO.

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 Philips Medical Systems Ltda..

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
    1714
  • Date
    2015-05-07
  • 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 record holder's information, if the gears are disengaged, the patient under examination procedure and with the compressed breast would be exposed to the risk of a potential adverse event due to the involuntary twisting of the 180 ° arm. The event has a high chance of occurrence. #### UPDATED ON 07/18/2017, the company sent a report of completion of the field action proving the accomplishment of correction, as planned.
  • Cause
    Possibility that the internal gears used for the rotating movement of the mammograph arm disaggregate due to inverted mounting of a mechanical component called "bearing spacer".
  • Action
    The company will correct the position of the "bearing spacer", which will allow adjustment of the entire assembly, located on the arm of the mammograph. Customers must schedule a technical visit to perform this action. Any questions get in touch with the company. Action code: FCOLAS 002-2015.

Device

Mammo Graph Mammo and Mammo DR Mammography Unit, records 10216710296 and 10216710243, risk class ...

Manufacturer

Philips Medical Systems Ltda.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA