Events

Alerte De Sécurité sur fluid control systems Uteromat Model series A4058Números: 0006CM268 to 0006CM272, 0011CM286 to 0011CM295, 0101CM027 to 0101CM031, 0101CM476 to 0101CM480, 9606CE087 to 9606CE104, 9607CE336 to 9607CE345, 9701CE081 to 9701CE084, 9703CE061 to 9703CE070, 9709CE416 to 9709CE425, 9903CM294 to 9903CM303, 9904CM400 to 9904CM409, 9909CM059 to 9909CM064, 9909CM156 to 9909CM169; 11 additional units with serial numbers that do not exist in the old Olympus computing system

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 Olympus America Inc; WOM World of Medicine GmbH.

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
    311
  • Date
    2001-10-12
  • 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
    Volumetric readings of the fluid in the above units may not be displayed or the same readers may exhibit both the loss of fluid and the loss of volume of fluid in the display panel. also, units may not warn when the level is too low. the distributor began the correction by letter dated april 30, 2001.
  • Action
    Please verify receipt of the letter and the questionnaire dated April 30, 2001 from Olympus America. Identify and isolate any affected product in inventory. An Olympus America customer service representative will contact you by phone to have Airbone Express pick up the current Uteromat (s). Olympus America will upgrade the software so that the problems with the alarm and volume display are corrected. The repaired product will return in 5 business days. Complete the questionnaire and return it to Mary Anne Pizzinga, Olympus America by fax 1 (631) 844-5554. For more information, contact your local representative or directly with Olympus America at 1 (631) 844-5688 (in the United States).

Device

fluid control systems Uteromat Model series A4058Números: 0006CM268 to 0006CM272, 0011CM286 to 00...

Manufacturer

Olympus America Inc; WOM World of Medicine GmbH
  • Source
    ANVSANVISA