Rappel de Device Recall AGFA Digital Radiography XRay system DXD 100

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 AGFA Corp..

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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, x-ray, mobile - Product Code IZL
  • Cause
    When liquid comes in contact with the dx-d 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
  • Action
    Agfa Healthcare sent an "URGENT FIELD SAFETY NOTICE" dated June 6, 2014, to the US and Canadian customers. The letter described the safety alert and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was requested from the customers. Although medical staff are required to disinfect hands on a frequent basis, users must ensure that their hands are dry before using the touch screen of the DX-0100 because liquid residue may activate the action buttons on the touch screen. Customers were instructed: "Do not operate touch screen monitor with wet hands! "Do not let liquids come in contact with the touch screen while the DXD 100 is powered on! "Always double check your parameter settings prior to exposing the patient. We would like to remind you of this specific warning statement in the DX-0100 User Manual. Please complete the feedback form as soon as possible and return it to us by June 16, 2014. Should the above information not apply to your facility or should the device have been transferred to another organization, please be so kind as to indicate this on the attached feedback form and pass this Urgent Field Safety Notice to the organization where the device has been transferred. We thank you for your careful attention to this issue and your continued support. If you have any questions about this matter, please contact your local Agfa Healthcare organization: 1-877-777-2432, prompt 1 and reference PR1406020002


  • Modèle / numéro de série
    Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000315, A5411000331, A5411000332, A5411000141, A5411000144, A5411000038, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000333, A5411000334, A5410000038, A5411000019, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5410000016, A5410000039, A5410000021, A5410000023, A5411000074, A5411000080, A5411000024, A5411000184, A5411000193, A5411000196, A5410000100, A5410000114, A5410000115, A5410000116, A5410000117, A5411000342, A5411000343, A5411000344, A5411000366, A5411000368, A5411000237, A5411000027, A5411000020, A5411000021, A5411000132, A5411000070, A5411000078, A5411000082, A5411000154, A5411000156, A54110000107, A5410000082, A5410000066, A5411000236, A5411000155, A5411000151, A5411000148, A5411000149, A5411000134, A5411000120, A5411000125, A5411000147, A5410000079, A5411000185, A5411000191, A5411000192, A5411000194, A5411000239, A5411000052, A5411000030, A5411000314, A5411000348, A5411000268, A5411000347, A5411000349, A5411000140, A5411000142, A5411000097, A5410000022, A5411000017, A5410000027, A5411000153, A5411000233, A5411000234, A5411000235, A5411000318, A5410000044, A5411000037, A5410000043, A5411000181, A5411000158, A5411000152, A5411000263, A5411000309, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000159, A5411000041, A5411000050, A5411000088, A5411000247, A5411000079, A5411000040, A5411000240, A5411000085, A5411000277, A5411000278, A5411000279, A5411000280, A5411000281, A5411000282, A5411000245, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000039, A5411000032, A5411000083, A5411000122, A5411000108, A5411000110, A5411000241, A5411000246, A5411000114, A5411000033, A5411000139, A5411000312, A5411000182, A5411000190, A5411000218, A5411000249, A5411000084, A5411000098, A5411000238, A5411000116, A5410000042, A5411000023, A5411000337, A5411000338, A5411000340, A5411000314, A5411000117, A5411000121, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000363, A5411000034, A5411000025, A5411000081, A5411000146, A5411000092, A5411000093, A5411000026, A5411000068, A5411000131, A5411000060, A5411000018, A5411000100, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000285, A5411000311, A5411000286, A5411000062, A5411000136, A5411000178, A5411000179, A5411000283
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada.
  • Description du dispositif
    AGFA Digital Radiography X-Ray system DX-D 100 || Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
  • Manufacturer


  • Adresse du fabricant
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source