Events

Alerte De Sécurité sur 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

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 PROGENY INC.

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
    104
  • Date
    2001-01-24
  • 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 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.
  • Action
    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

Device

AUTOMATIC LINEAR COLLECTORS EUREKA (1) MODEL II, (2) MODEL III, (3) MODEL IV CONTINUOUS SID; LINE...

Manufacturer

PROGENY INC
  • Source
    ANVSANVISA