Alerta De Seguridad para Commercial name: Nuclear Imaging System. Technical name: Nuclear Imaging System. ANVISA registration number: 10310650051. Risk class: III. Affected model: Millennium VG, Discovery VH, Varicam. Serial numbers affected: Millennium VG, Discovery VH, Varicam

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.

1. Make sure that the collimator locking lugs are in the locked position all the time. Take special care after the collimator change procedure and make sure that the collimator locking lugs move from the OPEN position to the CLOSED position without applying excessive force. 2. Confirm that the collimator locking lugs are properly in the locked position before beginning care of the patient. 3. Monitor the patient and system throughout the scanning procedure. In case of collimator detachment, pull the patient release lever from the table to withdraw the patient as indicated in the user manual. 4. If there is any difficulty or error in the collimator change procedure at any time, follow the instructions in the user manual and contact GE Technical Assistance. 5. Make sure that the server in your machine uses the latest maintenance manual and preventive maintenance procedure. Prior to each maintenance event, the server should check for the most recent versions of the maintenance manual and preventative maintenance procedure available on the Internet at: http://apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+ Library If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 07/07/2017 - Date of notification notice to Anvisa: 11/13/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "