Events

Retiro De Equipo (Recall) de Device Recall Agfa Healthcare NX 3.0.8950 Imaging Processing Software

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 Healthcare 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
    77632
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2735-2017
  • Fecha de inicio del evento
    2016-12-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156969
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    A customer reported that when using an nx workstation with software version nx 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. after a short time the wrong image was replaced by the correct image, however the wrong image was used for transmitting to pacs.
  • Acción
    On December 22, 2016, an URGENT FIELD SAFETY NOTICE letter was sent either by mail or email. The letter included an acknowledgement form to be returned. The letter informed the customer of the problem and actions to be taken.

Device

Device Recall Agfa Healthcare NX 3.0.8950 Imaging Processing Software
  • Modelo / Serial
    2UA15205XC, 2UA161JNH, A5411002007, A5411001003, A5411001002, 5CG5164040, 2UA5481BVY, 5CG5171X81, A5411002026, A5411002025, A5410000039, 2UA62524PS, 2UA62524Q2, 2UA62524RK, A5411002031, 2UA61218G4, 5CG61266X6, 2UA61218GG, 2UA63825HQ, 2UA642306H, 2UA4161JMY, 2UA52524Y5, 2UA62524RJ, 2UA62524QV, 2UA62524QB, 2UA62524RJ, 2UA62524NS, 2UA62524PJ, 2UA62524Q9, A5411000155, A5411000151, 2UA62524PH, 2UA62524QL, 2UA62524QT, A5411000153, 2UA62524Q0, 5CG6126B9J, 5CG61266YW, 5CG61266VP, 5CG61268BG, 5CG612673N, 2UA6243GNY, 2UA62424R8, 2UA62524P4, 2UA62524RY, 2UA6243GPT, 2UA62524Q6, 2UA62524PR, A5411000152, 2UA63825HR, 2UA31000Q6, 2UA31000Q8, 2UA31000R5, 2UA31000QR, 2UA319120W, 2UA3191211, 2UA31000PS, 2UA31000QX, 2UA31000Q0, 2UA31000PX, A5411000346, A5411000232, A541000199, A5411000210, A5411000209, 2UA62524P8, 5CG61266R5, 5CG5295760, 5CG5285W67, 5C5285W7P, 5CG5285W9Y, 5CG5285W5R, 5CG528W7B, A5411001163, A5411000468, 2UA52524XM, 2UA5481BTP, A5411000145, 2UA25009HM, A5411001064, A5411000159, 2UA3380VMW, 2UA3380VMG, 2UA3461QSD, A5411001039, A5411001066, A5411001065, A5411000230, A5411000177, A5411000174, CZC6349KSZ, 2UA62524RH, 2UA62524R4, 2UA6254Q7, A5411000116, A5411002095, A5411002093, A5411002092, A5411001173, A5411001172, 2UA6243GPK, 2UA6243GPL, 2UA62524QH, 2UA4150QFZ, 2UA4150QFQ, 2UA1110ZYG, 2UA3021KYP, 2UA52524XC, 2UA52524YK, 2UA52524YQ, A5411001105, MXL24220J8, A5411002030, A5411001089, A5411002058, 2UA2181HSV, A5411000238, 2UA6021JXG, 2UA511BZ2, A5411000341, A5411000340, A5411000337, 2UA5111C0V, CZ6357GKR, CZC6357GFM, A5411002051, A5411002048, A5411002047, A5411002052, A5411002049, A5411000549, 2UA62524RW, 2UA62524QS, 2UA62524P7, 2UA62524R7, 2UA62524QM, A5410001000, A5410000132, 2UA5170ZKM, 2UA5422QN4, 2UA62524PP, 2UA62524R6, 2UA1221B32, 2UA62524QD, A5411002033, 2UA62524RX, 5CG6126743, 2UA62524PB, 2UA44616DJ, 2UA63825J3, 2UA62524P6, 2UA62524QF, 2UA62524PL, 5CG61266QW, 2UA62524PN, 2UA62524RS, 2UA62524RQ, 2UA62524QJ, 5C61266Y4, A5411002064, A54110002059, CZC6349KXK, 2UA5111BZC, 2UA642306K, 2UA63825J4, 2UA64029N9, 2UA62524PD, 2UA62524P1, 2UA62524Q8, 2UA63825J6, 2UA63825JD, 2UA62524P0, 2UA63825HS, 2UA63825HN, 2UA63825J5, 2UA63825J8, 2UA61225X9, 2UA62524PT, 2UA63825J0, 2UA62524PV, 2UA5111BYZ, 5CG61266YZ, 2UA62524NY, 2UA62524RV, 5CG61266MG, 2UA63825JC, 2UA63825HX, 2UA62524QZ, 2UA62524QR, 2UA62524PF, 5CG53032V5, 2UA52223Q2, 2UA52223Q4, 2UA51519JR, 2UA62524RP, 2UA32878M, 2UA5451JKP, 2UA62524RG, 2UA62524R5, 2UA62524RN, 2UA63825HM, A5411002022, A45411000018, A5411002057, 2UA63825HZ, A5411000180, 2UA15205X9, 2UA62524NX, 2UA31000Q9, A5411000179, 2UA5451JL2, 2UA1510H6B, 2UA5311CS3, 2UA61218GT, CZC6057ZSL, A5411002024, 2UA62524RM, 2UA62524PY, 2UA1510H60, 2UA1510H5C
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada
  • Descripción del producto
    Agfa Healthcare NX 3.0.8950 Imaging Processing Software
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Dirección del fabricante
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Empresa matriz del fabricante (2017)
    Agfa-Gevaert NV
  • Source
    USFDA