Events

Rappel de Device Recall Etac Relax

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 Etac Supply Center Ab.

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
    71707
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2381-2015
  • Date de mise en oeuvre de l'événement
    2015-07-12
  • Date de publication de l'événement
    2015-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138795
  • 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
    Adaptor, hygiene - Product Code ILS
  • Cause
    The recalling firm has received reports of a malfunction of the relax wall mounted shower seat where the wall bracket has cracked or broken.
  • Action
    Etac sent an Urgent Field Safety Notice dated July 2015 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that there was no reason for an immediate stop of using Relax, however, as an intermediate precautionary action awaiting replacement, consumers were requested to be observant and inspect the Relax to see if there are visible signs of a crack. Customers with questions were advised to contact their Etac distributor or the Etac coordinator at 1-800-336-7684 or fax 1-704-882-0751.

Device

Device Recall Etac Relax
  • Modèle / numéro de série
    The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including FL, AZ, and CA.
  • Description du dispositif
    Etac Relax wall mounted shower seat || The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • Adresse du fabricant
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • Société-mère du fabricant (2017)
    Nordstjernan Ab
  • Source
    USFDA