Events

Safety Alert for Product Name: CT Scanning Systems (Model: Revolution CT) /// Record Number: 80071260343 /// /// Lots: ALL LOTS /// Product Risk Class: III.

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 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
    1903
  • Date
    2016-05-20
  • 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
    Possible consequences of using the product at risk: If the bed of the Revolution CT performs an unintentional lowering movement, it is possible to cause injury to patients. The lesions may involve pinching or crushing of one hand / end if it is caught between the bed and the inside of the gantry. However, patients are instructed to keep their hands and feet close to themselves and on the inner surface of the bed. An awake patient can react by avoiding an injury by removing one end of the bed path, which is also able to signal in case of complications. Unconscious or sedated patients may not be able to react / signal, however, according to good clinical practice, they should be monitored closely. No injury was reported due to this safety problem. ### 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 security warning to the client, updating the ANVISA registry and replacing parts.
  • Reason
    Ge reports that it became aware on february 8, 2016 of a potential safety concern with the revolution ct patient table, which may result in unintended movement in exams involving patients of high stature. the revolution ct bed may descend without commands after user activation.
  • Action
    Action code: IMF 25468 /// Field Correction - Parts / Parts Correction /// Clients may continue to use the systems normally. Users should make sure to follow the Patient Positioning notice described in the Revolution CT User Manual. Information and warnings can be found in the Revolution CT User Manual (5480385-1EN) - Mechanical Safety - Patient Positioning (Chapter 3, Section 9.2 - Safety). To prevent the patient's extremities from being pinched or crushed, keep your hands and feet away from the edges of the table / bed, the surrounding equipment, or the area between the base and the side panels of the table. Users should also take special care when positioning patients of high stature./// LETTER TO THE CUSTOMER IN ANNEX.

Device

Product Name: CT Scanning Systems (Model: Revolution CT) /// Record Number: 80071260343 /// /// L...

Manufacturer

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