Events

Alerte De Sécurité sur Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX, DDXXX, DEXXX (where X in any position corresponds to numbers 0 to 9), DG0001 to DG0129, DH0001 to DH0033, DJ0001 to DJ0152, DK0001 to DK0076

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 North America.

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
    691
  • Date
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The c-tilt support, in the aforementioned x-ray systems, can bend or break, allowing the c-arm to fall out of the support and reach a patient. the manufacturer notified by letter dated 27 september 2002.
  • Action
    Make sure you received the letter from Philips on 27 September 2002. Identify and isolate any affected product in your inventory. Contact your local Philips representative for additional information, to schedule a technical visit in your area, and to arrange the units in your inventory. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Mobile Model X-ray Systems BV 300. Parts Nos .: 9896 000 06801, 9806 000 06802; In Series: DBXXX,...

Manufacturer

Philips Medical Systems North America
  • Source
    ANVSANVISA