Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Ltda.; SIEMENS AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1488
  • Date
    2014-12-22
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    Siemens identified a possible issue, which is currently being investigated and determined the need to verify syngo.Plaza with data file in status "2" (archived = true) for the sts short-term data storage, but not available in the long-term lts data storage. analyzes have shown that after restarting the process of receiving an image, a named and identified file can be used, which can cause a mixture of patient data. in this case, a subsequent acquisition operation of a new image may reuse the name of an already allocated image file. if this occurs, the system continues to operate and all subsequent operations will be processed successfully, however, a mix of patient data may have occurred. after you delete the affected file from the sts short-term data store, the inconsistency will be detected as other archiving failure operations.
  • Action
    The company advises to wait for the Company's scheduling to update software and follow the guidelines contained in the letter, which should be archived. If you have any questions, please contact the Customer Service Center: 0800 55 48 38

Device

Image Archiving and Communication System (PACS), Model Syngo.Plaza; Registry 10234230177, Serial ...

Manufacturer

Siemens Ltda.; SIEMENS AG
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA