Events

Safety Alert for X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III Model Affected: Brivo OEC 715, Brivo OEC 785, Brivo OEC 865 Affected serial numbers: • GE Brivo OEC715: Series numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051; • GE Brivo OEC785: Series numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152; • GE Brivo OEC865: Series numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029

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 Hualun Medical Systems CO., LTD / GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares 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
    2142
  • Date
    2016-10-04
  • 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
    Before starting the procedure, the operator must check that the C-arc moves up and down normally, and that the emergency stop button is working correctly. If the C-arc moves up or down without a command, during a procedure, the user must press the emergency stop button to prevent the C-arc from colliding with medical instruments. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Reason
    The plate that controls the vertical movement of the c-arc can fail and result in c-arc movement up or down, without command. there were no injuries reported as a result of this problem. however, this problem can cause soft tissue damage if the c-bow moves down during a surgical procedure and collides with the medical instruments.
  • Action
    Field Action IMF Code 15132 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will make correction in the field.

Device

X-ray Mobile Device X-ray Mobile Device Registration Number ANVISA: 80071260301 Hazard Class: III...

Manufacturer

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