Alerte De Sécurité sur Trade name: PACS-IW. Technical Name: Software. ANVISA registration number: 80071260105. Risk class: II. Model affected: PACS-IW. Serial Number Affected: PACS-IW (80071260105)

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 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; Dynamic Imaging LLC..

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
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Until the update is available to correct this problem, the following actions are recommended. 1. Use the image counting within the QC process to alert the user to a discrepancy in the number of images transmitted from the mode regarding the number of available images. The. If a discrepancy is identified, try retransmitting the exam to the PACS. B. If retransmission is unsuccessful, a GE Healthcare Maintenance representative should be contacted to assist in resolving the impacted examination. Urgent cases impacted by this problem should be interpreted in the modality. 2. If the DICOM storage commitment is configured and in use, no commit notification will be sent to the imaging mode that has been affected by this problem. 3. Attention should be paid to the previous cases, which were acquired prior to the application of the safety instructions given in this communication, as they may be affected by the safety problem. 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: 09/25/2017 - Date of notification notice to Anvisa: 09/02/2018 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. (...) "
  • Cause
    A database management error may occur during the image acquisition process, which can affect the integrity of the acquired images. there is a possibility that one or more "image series" (that is, all images within a set of images) may be missing in an examination without the user warning display. although this is rare, this can occur with imaging studies that have a very small number of images per series. for example. chest examination by cr with 1 image per series. there were no injuries reported as a result of this problem.
  • Action
    Field Action IMF Code 85443 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Will make correction in the field.