Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PROGENY INC.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    104
  • Date
    2001-01-24
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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

Manufacturer

  • Source
    ANVSANVISA