Alerte De Sécurité sur Trademark: IntelliVue iX Information Center. Technical Name: Software. Registration number ANVISA: 10216710250. Risk class: III. Affected Model: M3290B .. Number of Series Affected: 5750-5JHY-H; 087W-4VK7-W; 6W4K-0GN9-A; 453E-1AHM-H; 7216-59N8-6; 7R0L-6AMX-B; 5G75-5WKF-8; 745P-55J9-R; 3H1F-42GL-N; 0R3L-5PP3-T; 3N4R-43JR-A; 2N H-7HN-N; 5W0N-4FL0-2; 5K15-0MNA-D; 005J-0ZNF-1; 5636-61K2-R; 4V6P-2XHV-X; 2A1H-7HJU-U; 312C-5MGJ-2; 2C49-12JD-P; 5F5Y-11KG-C; 7B7G-2UGW-5; 7J34-24GX-T; 2W76-3ZKP-P; 597Y-7BG9-Y; 1W5W-66H9-W; 2E4R-43JR-3; 7V5H-1YML-2; 204 D-2HJF-P; 412W-1VNP-R; 0K52-6KKD-7; 6A78-1LMN-3; 6F2P-1RHT-T; 0T6R-3KLU-9; 080V-7AHH-6; 6W33-5BNT-X

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.

To avoid this problem, do not intentionally restart any surveillance station that has been operating normally since the new year. You can use the workflows in the Annex "Alternate Workflows for PIIC IX" to avoid operations that may lead to the resumption of the surveillance station. When a patient is discharged, confirm that the patient has been discharged. 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 Vigilance should be made through System NOTIVISA. To access the System, you must register and select the Health Professional option, if you are a 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: 09/01/2018 - Date of notification notice to Anvisa: 03/01/2018 The company holding the registration of the affected product is responsible for contacting, in a timely manner , its clients in order to guarantee the effectiveness of the ongoing Field Action. The solid responsibility of the distribution chain and use of the products for health in the maintenance of its quality, safety and efficacy, as well as of the effectiveness of the Field Action, expressed by RDC 23/2012 : "(...) Art. 2" A holder of registration of product for the health of the holder of the registration / registration of product for the health together with Anvisa. Single particle. The registration holder, as well as the 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 products for sa To the end consumer. Art. 12 Distributors of health products shall forward to the holder of registration, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) ¡±