Events

Safety Alert for Computed tomography system, Revolution CT model, risk class III, registration 80071260343. All equipment with software version 15MW03.12.

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

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
    1738
  • Date
    2015-11-04
  • 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
    According to the registry holder, no injuries related to the problem were reported. The beam-hardening artifact between brain tissue and bone often occurs on CT scans and will rarely manifest itself in a way that could be misinterpreted as a true pathology. In addition, the effects of beam hardening are widely known by radiologists and other physicians who evaluate these exams. Therefore, suspected findings on a CT scan of the head would be identified as artifacts. Additional information such as patient history and physical examination (eg, making a complaint, injury mechanism, neurological evaluation, etc.). The loss of other radiological findings (eg, absence of mass effect, edema, medical line deviation) would also increase suspicions that these results are artifacts. However, other examinations can also be performed, such as Magnetic Resonance Imaging. ### Update of the field action: UPDATED ON 10/23/2017, the company submitted the field action completion report proving the sending of the notice customer safety with evidence from science and all actions completed.
  • Reason
    Failure in image quality can generate beam-hardening artifacts, with the possibility of mimicking pathologies between brain tissue and bones in head examinations.
  • Action
    Software update. Action code: IMF 25465. The company advises that users can continue to use Revolution CT systems. For routine head examinations, it is recommended that users position the patient's head so that the orbitomeatal line is parallel to the examination plane and that they use GE 21.1 or 21.2 Protocols (Reference Protocol Guide 5567862-1EN Rev 2 ). To further reduce the occurrence of beam hardening artifacts, use the 40 mm collimation. The introduction of 40 mm collimation for routine head examinations will result in more desk transitions, so collimation should be determined (40, 80, 120 or 160 mm) to better meet the needs for head imaging in radiological practice . //// When performing head examinations, users should not forget to follow the CT User's Guide for information on how to help minimize these types of artifacts during routine head examinations. Information and warnings can be found in the Revolution CT User Manual (5480385-1XX Rev 2). ////// For possible artifacts during imaging: • Safety Chapter - Chapter 3, Section 14.1 .; // For beam hardening questions on head exams: • Scan Chapter - Chapter 11, Section 4.5.4.2. • Chapter Pediatric and Small Patient Chapter - Chapter 5, Section 3.5.5. • General Information Chapter - Chapter 21, Section 6.1.

Device

Computed tomography system, Revolution CT model, risk class III, registration 80071260343. All eq...

Manufacturer

GE Healthcare do Brasil; GE MEDICAL SYSTEMS LLC