Events

Rappel de Device Recall EKOS Cart

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 EKOS Corporation.

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
    75100
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2890-2016
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • Date de publication de l'événement
    2016-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149355
  • 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
    Stand, infusion - Product Code FOX
  • Cause
    Casters on the ekos carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
  • Action
    The firm, EKOS, sent an "URGENT FIELD SAFETY ACTION" letter dated August 22, 2016 to its customers. The letters were sent to customers informing them of the field safety action, how to identify the affected carts at their facility and instructing customers locate the cart, quarantine it and do not use the cart for any procedures. A representative from EKOS Corporation will be contacting customers in the near future to arrange a date and time when the cart at a facility can be inspected and any affected caster(s) replaced. As the cart is inspected, it will be tagged to easily identify it and confirm it has been inspected and repaired as necessary. Customers will be provided with a copy of the inspection/repair form for the cart they inspect. Please retain that form for records. If customers have any questions, please contact EKOS Customer Service at 1-888-400-3567 or your local EKOS representative.

Device

Device Recall EKOS Cart
  • Modèle / numéro de série
    Lot numbers: 030915 032615 040915 061515 071515 081715 103015 120715 010416 011816 022216 032116 052416
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
  • Description du dispositif
    The EKOS cart has the catalog number 700-60101. || The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Adresse du fabricant
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    USFDA