Events

Safety Alert for Commercial name: Innova Digital X-ray Imaging System. ANVISA registration number: 80071260060. Risk class: III. Models: 2000, 2100 IQ, 3100, 3100-IQ, 4100 and 4100-IQ ... All Mavig monitor suspensions manufactured before January 2009 and installed in the fluoroscopy imaging systems INNOVA 2000, INNOVA 2100, INNOVA 2100IQ, INNOVA 3100, INNOVA 3100 IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 2131IQ, INNOVA 3131 / IQ, Advantx LCV +, Advantx LCA, Advantx LCLP +, Advantx LCN +.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE MEDICAL SYSTEMS S.C.S.; GE Healthcare do Brasil Ltda..

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
    1786
  • Date
    2015-01-05
  • 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
    This fall could result in personal injury to a person. There were no injuries reported as a result of this event. /// Users should avoid placing the monitor on patient, user, or other auxiliary personnel. If the user notices any unusual movement or laxity in the Mavig Monitor suspension, the Mavig Monitor should contact the GE Healthcare representative. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Reason
    Possibility of dropping a mavig suspension arm with monitor set.
  • Action
    a) Risk Classification: CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. b) Field Action Classification: Field Correction - Parts / Parts Correction c) Field Action Code: IMF 12239. d) Recommendations to users and patients: Users should avoid placing the monitor on patient, user or other personnel help. If the user notices any unusual movement or laxity in the Mavig Monitor suspension, the Mavig Monitor should contact the GE Healthcare representative. Follow the precautions below before continuing to use the monitors: 1. Position the monitor suspension in the most frequently used position and further limit movement as much as possible. 2. Report clearly (for example, through signs and verbal instructions) to users and other helpers who may come into contact with the system so they do not move the monitor's suspension after it is in position. GE Healthcare will send a representative to inspect the system.

Device

Commercial name: Innova Digital X-ray Imaging System. ANVISA registration number: 80071260060. Ri...

Manufacturer

GE MEDICAL SYSTEMS S.C.S.; GE Healthcare do Brasil Ltda.