Events

Safety Alert for Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equipment ANVISA Registration Number: 80071260352 Hazard Class: II Model Affected: Signa Creator; Signa Explorer Affected Serial Numbers: Signa Creator and Signa Explorer Equipment

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 Healthcare (Tianjin) Company Limited e 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
    2139
  • Date
    2016-09-09
  • 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
    You may continue to use the system, but you must ensure that the RF power monitor is reactivated when starting a new patient examination if a redefinition of TPS has been performed during the patient examination. ### 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 function of the rf power monitor is to monitor the output power of the rf amplifier and to detect if the power of the rf transmission exceeds the expected amount that is generated. if the output power of the rf amplifier exceeds the specified sar (specific absorption rate), the rf power monitor will stop scanning. ge healthcare has identified that if the user performs a tps (transceiver processing and storage) reset during patient scanning, the rf power monitor is disabled for the remainder of this patient scan. this prevents the power monitor from detecting any subsequent failure of the rf transmission function.
  • Action
    Field Action Code IMF 67921 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

Commercial Name: Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Imaging Equ...

Manufacturer

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