Events

Rappel de 1.5T HD Head Neck Spine Array, Model 2416329.

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 USA Instruments Incorporated.

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
    36612
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0163-2007
  • Date de mise en oeuvre de l'événement
    2006-09-20
  • Date de publication de l'événement
    2006-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49005
  • 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
    MRI - Product Code MOS
  • Cause
    The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized rf burn and/or electrical shock to a patient on which the device is being used.
  • Action
    The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 09/20/2006. The notification informs the customer(s) of this potential problem and the three (3) conditions under which this problem (patient becoming burned) could possibly occur. The notification goes on to inform the customers that the firm will be upgrading all 1.5T HD Head Neck & Spine Arrays so as to eliminate this potential hazard, at no cost to the customer and that a Service Representative will be contacting the customer in order to make arrangements to upgrade the coil on-site. A toll-free telelphone no. is provided in the notification letter for questions and/or comments. Lastly, the recall notification provides interim instructions which the customer should follow. The operator/technician should: ask that the patients place their hands at their sides during a scan; immediately discontinue the scan if the patient undergoing the scan starts to move; and stay in constant visual and oral contact with the patient undergoing the scan at all times. For the 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System, The user/customers were notified of this recall with an ''Urgent Customer Safety Notification'' which was sent to the user/customers via Certified mail per recall letter dated 10/13/2006.

Device

1.5T HD Head Neck Spine Array, Model 2416329.
  • Modèle / numéro de série
    The following Serial Numbers of this device were subject to recall: 101, 201, 202, 203, 204, 205, 206, 207, 208, 308, 309, 310, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325, 326, 327, 328, and 329.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, (states of CA, NJ, PA, MN, IA, MA, WI, WA, and FL) Switzerland, the United Kingdom, France, Canada and Finland.
  • Description du dispositif
    1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.
  • Manufacturer
    USA Instruments Incorporated

Manufacturer

USA Instruments Incorporated
  • Adresse du fabricant
    USA Instruments Incorporated, 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA