Events

Safety Alert for Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affected model (s); and Lot (s) / Serial number (s) affected: OPTIMA XR220AMX ... The Optima XR200amx and BRIVO XR285amx X-ray systems (ANVISA Registration 80071260246) are also affected.

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

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
    1785
  • 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
    Dropping the arm assembly can result in personal injury to a person. To date, there have been no incidents or injuries reported as a result of this security problem found internally. ### Field Action Update: UPDATED ON 10/23/2017, the company filed the field action completion report verifying the sending the security warning to the client with evidence of science and all actions completed.
  • Reason
    Problem related to the operation of the safety lock of the column that supports the horizontal arm. this safety latch mechanism acts as backup in the unlikely event of the primary safety cable breaking.
  • Action
    CLASS III - Situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences. / / Field Action: Field Correction - Parts / Parts Correction. /// Field Action Code: IMF 10906./// The system may continue to be used. A GE Healthcare representative will contact the establishments that have equipment affected by this field action to arrange for correction.

Device

Trade name: Optima X-ray system. ANVISA registration number: 80071260245. Risk class: III. . Affe...

Manufacturer

GE MEDICAL SYSTEMS LLC; GE Healthcare do Brasil