Events

Safety Alert for Technical Name: CT Scanner ANVISA Registration Number: 80071260079 Hazard Class: III Model Affected: Optima CT 540 Serial Numbers Affected: • BrightSpeed ​​Select (ANVISA 80071260096) • Optima CT 540 ANVISA 80071260079) • Optima CT 580, Discovery RT (ANVISA Registration 80071260129) • Optima CT660, Revolution EVO (ANVISA Registration 80071260119) • Discovery CT590RT (ANVISA Registration 80071260132) • LightSpeed ​​VCT (ANVISA Registration 80071260076) • LightSpeed ​​RT16 (ANVISA Registration 80071260091) • Discovery PET / CT 600, 690 (ANVISA Registration 80071260109) • Discovery PET / CT 610, Discovery PET / CT 710 (ANVISA Registry 80071260295) • Discovery IQ (ANVISA Registration 80071260344); • Discovery MI, Discovery MI DR (ANVISA Registration 80071260295) • Optima PET / CT560 (ANVISA Registration 80071260130) • Discovery NM / CT670, 670 Pro, 670 ES (ANVISA Registration 80071260354)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE HANGWEI MEDICAL SYSTEMS CO, LTD..

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
    2302
  • Date
    2017-05-26
  • 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
    Systems can continue to be used safely. To do so, all users should adhere to the following instructions to avoid the possible occurrence of this problem: 1. Review the "Emergency Devices" section in your user manual. An update to the User's Guide is included in this package. Use the Emergency Stop Button only for patient-related emergencies. 2. If you press the Emergency Stop Button during the preparation period, always finish the current exam and start a new examination, including observation scans, to avoid incorrect timing of preparation time.
  • Reason
    A problem has been identified that can result in the sweep firing before the time required for patient preparation is completed. this problem occurred only once, in clinical use, in a particular situation, in which a very specific set of steps were performed. more specifically, if an examination is interrupted during the patient's preparation period using the emergency stop button and the scan is resumed, the next time interval for the preparation may be less than expected. in this case, if there are personnel present in the examination room, at the time of the start of the premature sweep, they may be exposed to secondary radiation.
  • Action
    Field Action IMF Code 25474 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will update, correct or supplement the instructions for use.

Device

Technical Name: CT Scanner ANVISA Registration Number: 80071260079 Hazard Class: III Model Affect...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE HANGWEI MED...