Events

Rappel de Device Recall Highlow:x

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Snug Seat Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    50206
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0651-2009
  • Date de mise en oeuvre de l'événement
    2008-11-06
  • Date de publication de l'événement
    2009-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74984
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    chair - Product Code IMS
  • Cause
    Breakage in the welds was discovered in a section of the chair frame.
  • Action
    Consignees were notified by letter dated 11/6/2008. Snug Seat sent a repair kit to their retail dealers on 11/18/2008. The kit includes a safety plate, written and video replacement instructions as well as the tools (allen wrench, crescent wrench and two nuts) necessary to make the safety update. Customers were identified using purchase order numbers, and product serial numbers to enable the dealers to identify the purchaser of the product. Due to HIPPA regulations, purchaser information was not available to Snug Seat, Inc. to contact directly. Written notification will be followed up with a telephone call to each dealer to ensure they have received the retrofit kit. Snug Seat will also insure they understand the importance of the kit and how to properly install and document receipt of the update for their customers.

Device

Device Recall Highlow:x
  • Modèle / numéro de série
    Article numbers 8911605-02, 8911605-02E, 8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between 8/24/2007 and 10/3/2008.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    High-low:x frame for the x:panda mechanical chair.
  • Manufacturer
    Snug Seat Inc

Manufacturer

Snug Seat Inc
  • Adresse du fabricant
    Snug Seat Inc, 12801 E Independence Blvd, Stallings NC 28105
  • Source
    USFDA