Safety Alert for Commercial Name: Angiographic X-ray System / Image Guided System / Innova Cardiovascular Imaging System. Technical Name: Hemodynamics and Angiography Equipment / Angiography Equipment / Angiography Equipment. ANVISA registration number: 80071260269. Risk class: III. Model affected: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305). Number of Batch / Series Affected: Discovery IGS IGS 730, Discovery IGS 740 (80071260304) / Innova IGS 520, Innova IGS 530, Innova IGS 540 (80071260269) / Innova IGS 620, Innova IGS 630 (80071260305)

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.

Before each use, make sure that the IGS system is fully functional as indicated on the GE product label. Follow procedures established before and during each use to administer the patient in the event of a repeated X-ray cancellation error during the procedure or in the event of a complete loss of fluoroscopic viewing ability. If the problem persists, contact your local GE Healthcare representative. Wait for the product to be corrected by the company. 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: 09/02/2018 - Date of notification notice for Anvisa: 04/18/2018 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. (...) "