Events

Alerte De Sécurité sur Clear Tape Electromagnetic Electrode: (1) Model 1680 Radiotranslucent, (2) Model 1690 UltraTrace Long-term adult multi-use monitoring. Catalog No. (1) 1680-001, 1680-005, 1680-030; (2) 1690-001, 1690-003, 1690-005, 1690-010, 1690-030; Lots Nos .: (1) 9909181, 9909231, 9909232, 9909271, 9909272, 9909291, 9909292, 9910011, 9910012, 9910052, 9910061, 9910071, 9910081, 9910082, 9910131; (2) 9909131, 9909141, 9909142, 9909152, 9909152, 9909152, 9909202, 9909202, 9909111, 9909241, 9909241, 9909251, 9909291, 9909291, 9909301, 9910041, 9910051, 9910052, 9910071, 9910081, 9910121, 9910122, 9910132, 9910141, 9910142 , 9910151, 9910192, 9910202, 9910221, 9910261, 9910262, 9910271, 9910291, 9911011, 9911031, 9911041

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 CONMED Corp.

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
    236
  • Date
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Some electrocardiographic electrodes (ecgs) of the aforementioned lots may show separation of the sensitive element from the electrode body, causing electrode malfunction. the manufacturer initiated a removal by letter dated september 20, 2000 and faxed on september 21 and 22, 2000.
  • Action
    Make sure you have received the letter, return form, and business letter return envelope sent on September 20, 2000, and faxes dated September 21 or 22, 2000 from Conmed. Identify and isolate any defective product from your inventory. Complete and return the form in the envelope provided. Immediately return defective product by UPS or equivalent delivery service to Conmed, Attention: Returned Goods-ECG Recall, at the above address. If you have distributed any problem products, please contact your customers, and ask them to return the product to the address listed. Conmed will replace all returned electrodes and will reimburse shipping costs. For more information, contact your local representative or directly with Sandra Flack, Conmed, at 1 (315) 797-8375 in the USA.

Device

Clear Tape Electromagnetic Electrode: (1) Model 1680 Radiotranslucent, (2) Model 1690 UltraTrace ...

Manufacturer

CONMED Corp
  • Source
    ANVSANVISA