Events

Alerte De Sécurité sur SSCOR Electric Suction Pumps (1) Model 2500, (2) Model 10552, (3) Model 15002, (4) Model 40014, (5) Model 45000, (6) Model 64000, (7) Model 64000-220, 8) Model 90024, (9) Model 90032. Series Nos.: (1) 250 to 1027, (2) 2655 to 3152, (3) 628 to 3603, (4) 5802 to 6499, (5) 1142, (6) 4881 to 8381, (7) 1008 to 1128, (8), 1854 to 2290, (9), 2216 to 2388

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 SSCOR 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
    214
  • Date
    2000-12-01
  • 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
    There may be cracks in the plastic fuse holders where the fuse necessary to recharge the described suction pumps is located. these cracks may cause the fuse to fall from the stand or prevent the unit from recharging. the manufacturer commenced a mail removal on june 28, 2000.
  • Action
    Make sure you have received the correspondence dated June 28, 2000 and the response card with the corrections on the SSCOR equipment. Identify and isolate any affected product from your inventory. Inspect the pump harnesses by removing the bolts connecting the top cover to the back panel to the metal units or by opening the fabric cover zipper or by lifting the velcro tab to the flexible units. If you find any cracks or problems in the fuse holder, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 ​​in the United States for parts replacement or to schedule fabric repair for the suction pump. Fill in the Equipment Correction Response Card and return it to SSCOR by the postal delivery service to the address listed, accompanied by the damaged product. For more information, contact Scott Eamer, SSCOR, at 1 (818) 504-4054 ​​in the United States.

Device

SSCOR Electric Suction Pumps (1) Model 2500, (2) Model 10552, (3) Model 15002, (4) Model 40014, (...
  • Modèle / numéro de série
  • Manufacturer
    SSCOR Inc

Manufacturer

SSCOR Inc
  • Source
    ANVSANVISA