Safety Alert for Commercial name: ACUSON Diagnostic Ultrasound System. Technical Name: Ultrasonic Apparatus. ANVISA registration number: 10345162017. Class of risk: II. Model affected: ACUSON S2000. Serial numbers affected: 211397; 211771; 211784; 213087; 213596; 213886; 213936; 214179; 214493; 214831; 215336; 215365; 215368; 215383; 215402; 215421

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.

Perform the following recommended test before using the 18L6 HD transducer to avoid the potential risk associated with the problem: 1. Connect the 18L6 HD transducer to the ultrasound system and place the gel-coated fingertip on the surface of the equipment. Slide your finger across the surface of the transducer. If finger echo is displayed in triplicate, turn the transducer off and on again and repeat the test. 2. It is also recommended to re-examine all previous breast exams performed with the 18L6 HD transducer with software in the VD10A or VD10C versions to confirm that no triplicate image was used as part of the diagnosis. 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 - Date of identification of the problem by the company: 06/09/2017 - Date of notification notice to Anvisa: 09/25/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner 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. (...) "