Events

Rappel de Device Recall Aplio XG model SSA790A

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 Toshiba American Medical Systems 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
    55941
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2981-2011
  • Date de mise en oeuvre de l'événement
    2010-06-02
  • Date de publication de l'événement
    2011-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92271
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Cause
    Toshiba america medical systems inc (tams) is initiating a field correction on the the aplio xg model ssa-790a because it did not meet the requirement of clause 15b, iec60601-1 which requires that the residual voltage shall not exceed 60v after 1 second from taking off the ac plug.
  • Action
    Toshiba America Medical Systems (TAMS) sent an "URGENT:MEDICAL DEVICE CORRECTION' letter dated June 2, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to be careful not to touch the contacts or prongs on the AC plug within two seconds after unplugging the system from a wall socket. This precaution is to be adhered to until a Toshiba Service Representative replaces the power supply. Customers are to complete and return a Customer Reply Form and fax to 877-349-3054. Customers with questions regarding the notification should contact the Director of Regulatory Affairs at (800) 421-1968 or call their local Toshiba Representative at (800) 521-1968.

Device

Device Recall Aplio XG model SSA790A
  • Modèle / numéro de série
    4899 5131, 5132, 5133, 5134, 5224, 5139, 5260, 5261, 5369, 5256, 5367, 4883, 4884, 5370, 5374, 5375, 5264, 5257, 5135, 5223, 5379, 5262, 6283, 4886, 5258, 5382, 5383, 5384, 5385, 5216, 4887, 4897, 4898, 5027, 5380, 4982, 5026, 5137, 5138, 5219, 5220, 4979, 5465, 4900, 5466, 4978, 5377, 5136, 5376, 5072, 5071, 5221, 5215, 4981, 5371, 5372, 5373, 5029, 5030, 5068, 5069, 5070, 5222, 4980, 4885, 5259, 5028, 4896, 5368, 5217, 5218, 5140, 5265, 5364, 5365, 5366, 5381, 5467, 5468, 5469, 5470, 5471, 5472, 5473, 5474
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Aplio XG model SSA-790A || Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and operability (reflecting the XG (next Generation) in its name), and can be used with ease for research as well as for routine clinical studies.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA