Alerta De Seguridad para AUTOMATIC LINEAR COLLECTORS EUREKA (1) MODEL II, (2) MODEL III, (3) MODEL IV CONTINUOUS SID; LINEAR MANUAL COLLECTORS EUREKA (EUREKA LINEAR MANUAL COLLIMATORS): (4) MODEL MC150, (5) MODEL MC150-C (1) 70-4300X, (2) 70-53XXX, (3) 70-750XX, (4) 70- 630XX, (5) 70-631XX; WE. OF SERIES: (FROM 1 TO 5) FROM FT92178 TO FT92232, FROM FW68001 TO FW68174; UNITS MANUFACTURED IN SEPTEMBER AND OCTOBER 1999

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PROGENY INC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    104
  • Fecha
    2001-01-24
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above related collimators were assembled in an inappropriate form. there are 4 screws that coupled the collimators to your box; in some of the above related collimators, shorter bolts were used. these screws can afroux over time and make the box release. the first evidence of that condition is the froxing and a single distortion of the x-ray field. if the collimator is not repaired, the box can release from the base. the manufacturer started a removal through correspondence sent on january 24, 2001.
  • Acción
    MAKE SURE YOU HAVE RECEIVED CORRESPONDENCE FROM PROGENY, SENT ON JANUARY 24, 2001. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED IN ITS STOCK. CHECK YOUR RECORDS AND FIND ANY COLLIMATOR WITH THE SERIAL NUMBER BETWEEN THE ABOVE MENTIONED. PROVIDE PRODUCT LOCATION FOR RICARDO MOREIRA, ENGINEER OF PROGENY APPLICATIONS, BY TELEPHONE 1 (847) 850-3800, RAMAL 776, OR BY FAX 1 (847) 850-3801. THE INFORMATION IS REQUIRED FOR PROGENY TO ISSUE THE NECESSARY LETTER OF NOTIFICATION TO THE END USER. FOR FURTHER INFORMATION, PLEASE CONTACT PROGENY BY PHONE 1 (847) 850-3800

Manufacturer

  • Source
    ANVSANVISA