Events

Alerte De Sécurité sur Urological Tables HydraVision System Hydradjust IV (HydraVision System Hydradjust IV Urological Tables): (1) Reverse, (2) Reverse with color monitor, (3) Reverse for Right Volume, (4) Reverse Volume, 3, (6) Standard Color Monitor, (7) Standard Left, (8) Standard Volume, (9) Standard Color Monitor, (10) Standard W / 4: 3, (11) Reverse Volume; Hydradjust with Urological Tables: (12) Left Fixed Color Monitor, (13) Fixed Right. Parts Nos .: (1) 400001, (2) 400005, (3) 400017, (4) 400011, (5) 400007, (6) 400006, (7) 400002, (8) 4,00012, (9) 10) 400008, (11) 400015, (12) 400026, (13) 400025; Series No.s .: (1 to 11) all serial numbers; (12) 0297-0520, 0397-0521, 0397-0523, 0797-0501, 1196-0502, 3496-0505, 3596-0508, 3996-0511, 4796-0515; (13) 0397-0522, 0397-0524, 3496-0503, 3496-0504, 3596-0506, 3596-0507, 3896-0510, 4596-0512, 4796-0513, 4796-0514, 5196-0516 to 5196-0518 , 5296-0519

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 Liebel-Flarsheim Business/Mallinckrodt 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
    222
  • Date
    2000-12-08
  • 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
    Mechanical interference may occur at the aforementioned tables when they are then turned over 50 ° causing the tilt cylinder to separate from the pivot block, enabling the tables and tube arms to rotate freely down and injure patients or staff . the manufacturer initiated a removal by mail sent on june 8, 2000.
  • Action
    Make sure you have received the correspondence sent on June 8, 2000, and the Risk Analysis Form from Liebel-Flarsheim Business / Mallinckrodt. Identify and collect any affected product from your inventory. Make the following product evaluation to determine the current risk condition of your tables: (1) Set the table height to 40 inches or more. (2) Turn the table to the Trendelenburg position, or upside down, until the turn of the table stops. (3) By pressing the spin button, check the message in the Message Center, "The movement limit has reached the limit, please change the direction of movement", and listen if the pump motor is still in operation. If the message does not appear, or the -15 ° angle is not reached, or if the pump motor continues to run smoothly, If the angle is reached, the message will appear, and the pump motor will shut down, the pump will be switched off, the table will be functional and non-risky, but schedule a visit from the technician to Mallinckrodt. Immediately contact a local service representative or directly with Mallinckrodt at 1 (513) 761-2700 in the United States. evaluation of product has been completed, complete the Risk Analysis Form and return it to Mallinckrodt's Parts Department at fax 1 (513) 948-7226. For more information, contact your local representative or directly with Mallinckrodt at 1 (513) 761-2700 in the United States.

Device

Urological Tables HydraVision System Hydradjust IV (HydraVision System Hydradjust IV Urological T...

Manufacturer

Liebel-Flarsheim Business/Mallinckrodt Inc
  • Source
    ANVSANVISA