Events

Retiro De Equipo (Recall) de Device Recall AGFA Digital Radiography XRay system DXD 100

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por AGFA Corp..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68567
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2081-2014
  • Fecha de inicio del evento
    2014-06-06
  • Fecha de publicación del evento
    2014-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128232
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, x-ray, mobile - Product Code IZL
  • Causa
    When liquid comes in contact with the dx-d 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
  • Acción
    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

Device

Device Recall AGFA Digital Radiography XRay system DXD 100
  • Modelo / Serial
    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
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Dirección del fabricante
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA