Events

Alerte De Sécurité sur Information systems, laboratory - FlexiLab laboratory information systems: (1) Version 5.23, (2) Version 5.3

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 Sunquest Information Systems Inc.

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
    342
  • Date
    2001-11-23
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    A defect reported in the above information systems may result in incorrect data being filed in the patient file / dossier. the manufacturer has initiated the correction by product safety note number psn-01-l11, dated april 10, 2001.
  • Action
    Please verify receipt of Product Safety Notice number PSN-01-L11 dated April 10, 2001 from Sunquest Information Systems. If the product is in use, follow the established temporary procedures described in the Sunquest Information Systems note. Product repair can be obtained by contacting your local representative or directly with Sunquest Software Distribution at (1) (520) 570-2000 in the United States. For more information, contact Sunquest Information Systems at 1 (520) 382-6170. ANVISA is interested in following if there was adequate collaboration of the manufacturer with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Information systems, laboratory - FlexiLab laboratory information systems: (1) Version 5.23, (2) ...

Manufacturer

Sunquest Information Systems Inc
  • Source
    ANVSANVISA