Events

Safety Alert for Magnetic Resonance Imaging Technical Name: Magnetic Resonance Imaging Equipment ANVISA Registration Number: 80071260358 Hazard Class: II Model Affected: Pioneer Signa Affected Series Numbers: MAGiC (Magnetic Resonance Imaging) at Signa Pioneer and on systems running Application software, version DV25.1.

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 Japan Corporation.

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
    2144
  • Date
    2016-09-08
  • 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
    The user can continue to use MAGiC with the following precautions: be careful when analyzing the spaces of the CSF, its adjacent tissues and the posterior fossa, particularly in cases involving subtle pathology. If in doubt, you are advised to purchase the standard T2 FLAIR 2D or 3D series or the MAGiC series in a different orientation for cross-sequence comparison. It is always recommended to pay close attention to patient stabilization during scanning. ### 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 and replacement parts.
  • Reason
    Ge healthcare is aware of a potential security issue involving magic, a imaging application. images may present new artifacts in synthetic reconstructions in the magic t2 flair, which may be difficult to recognize without access to weighted images of the conventional t2 flair. the acquisition of magic is the only one in which all contrasts are acquired simultaneously; therefore any gross movement of the patient will impact all generated images and may further alter the presentation of the new artifacts mentioned above. there were no injuries reported as a result of this problem.
  • Action
    Field Action IMF Code 60903 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

Magnetic Resonance Imaging Technical Name: Magnetic Resonance Imaging Equipment ANVISA Registrati...

Manufacturer

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