Alerta De Seguridad para Image Archiving and Communication System (PACS), Model Syngo.Plaza; Registry 10234230177, Serial Numbers: 100193; 100180; 200284; 100220; 200298; 100222 and 100321

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.

The company informs that no case has been identified in Brazil. The record holder also informs that when an additional image is received, syngo.plaza may allocate the same file name to a new image, check that there is no file in the system, and after receiving the "available STS" signal, will add the entry of the new image in the database. Thus, there may be two references to the same image in the database. As soon as the new image is physically available on the STS, loading and archiving for both images will be indicated successfully, however, a mix of patient data may occur. - For the first series received, the incorrect image may be displayed, that is, for this series there may be an image with incorrect parameter, incorrectly scanned location such as head rather than knee and may have incorrect patient identification. This way, the text described in the image will not reflect the correct information. (The text described in the image will point to divergence of the patient name / area examined / analyzed parameter). - For the study received later, the image will be correct.