Events

Safety Alert for USER'S MANUAL FOR ECLIPSE TMR 2000 LASER SYSTEMS. SYSTEM SERIES NUMBERS: 20103, 20106, 20107, 20114, 20119 To 20150 , 2014, 20158 to 20160, 20164, 20165, 20202 to 20204, 20209, 20211, 20230, 20231, 20234, 20250 to 20254, 20260, 20264 to 20268, 20270 to 20273, 20278, 20279, 20283, 20286, 20287 to 20290 , 20293 to 20297, 20303 to 20317, 20319, 20321 to 20327, 20333 to 20487, 40103, 40106, 40107, 40110, 40112 to 40114, 40116.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TECNOLOGIAS CIRÚRGICAS ECLIPSE 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
    10
  • Date
    2001-03-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Laser use manuals violate health law as no longer recommended agenda for maintenance procedures including calibration periodicity.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON JANUARY 18, 2001. RELEVANT HOSPITALS, CLINICS AND SURGEONS SHOULD VERIFY RECEIPT OF NOTIFICATION AND ECLIPSE URGENT RESPONSE FORM. IMMEDIATELY DISCONTINUE USE OF THIS MANUAL, DISCONTINUE AND REPLACE WITH THE NEW VERSION. COMPLETE THE ECLIPSE URGENT RESPONSE FORM AND RETURN BY FAX 00XX 1 (408) 548-2169. FOR FURTHER INFORMATION, TELEPHONY TO ECLIPSE NO 00XX 1 (408) 465-1121.

Device

USER'S MANUAL FOR ECLIPSE TMR 2000 LASER SYSTEMS. SYSTEM SERIES NUMBERS: 20103, 20106, 20107, 201...

Manufacturer

TECNOLOGIAS CIRÚRGICAS ECLIPSE INC.
  • Source
    ANVSANVISA