Events

Rappel de Device Recall PowerPark

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 Sonosite, 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
    55874
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2116-2010
  • Date de mise en oeuvre de l'événement
    2010-05-27
  • Date de publication de l'événement
    2010-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92115
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • Cause
    Powerpark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
  • Action
    On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.

Device

Device Recall PowerPark
  • Modèle / numéro de série
    Serial numbers for the Stand Mounted Assembly (P12822):  03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG.      Serial numbers for the Docking Assembly (P12834):  03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
  • Description du dispositif
    PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. || The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Adresse du fabricant
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA