Events

Retiro De Equipo (Recall) de Device Recall ARIA versions 8.0 and 8.1

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 Varian Medical Systems, Inc. Oncology Systems.

¿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
    58112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1905-2011
  • Fecha de inicio del evento
    2011-02-18
  • Fecha de publicación del evento
    2011-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98370
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    An anomaly was identified in the aria version 8.0 and 8.1, when an image sequence template is added to a field in rt chart and a ciao (completely irradiated aperture opening) is calculated, the resulting ciao display at 4ditc may be incorrect.
  • Acción
    Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items. For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265. Europe +41 41 749 8844

Device

Device Recall ARIA versions 8.0 and 8.1
  • Modelo / Serial
    Model number: HIT-INFSYS: Code numbers:HIT1554 HIT3338 HIT2129R1 HIT2129M HIT2129R4 HIT0968 HIT2129R2 HIT3700 HIT2129R5 HIT3692 HIT2129R3 HIT1207 HIT0565 HIT0498 HIT1084 HIT3529 HIT1359 HIT1691 HIT1050 HIT3708 HIT0737 HIT3607 HIT1778 HIT2009 HIT1581 HIT2531 HIT1771 HIT1914 HIT0040 HIT0716 HIT0606M HIT0606R1 HIT1731 HIT1861 HIT1060 HIT1729 HIT1860 HIT0942 HIT3527 HIT3010 HIT3290 HIT3209 HIT2779 HIT2777 HIT3473 HIT1010 HIT0335 HIT0594 HIT1580 HIT3365 HIT3354 HIT3564 HIT2688 HIT2016 HIT3413 HIT0631 HIT1110R1 HIT1151 HIT1679 HIT0951M HIT0419 HIT1159 HIT3270 HIT2595 HIT0426 HIT2557 HIT0651 HIT0950 HIT1548 HIT3342 HIT3018 HIT2236 HIT1121 HIT0951R1 HIT1115 HIT3732 HIT1493 HIT0402 HIT1128 HIT1592 HIT1451 HIT3706 HIT0124 HIT0843 HIT1602M HIT1602R1 HIT1380 HIT3691 HIT1129 HIT0210 HIT1668 HIT2831 HIT1926 HIT2068 HIT1719M HIT1507 HIT2223 HIT0510 HIT0195M HIT0813 HIT0139R1 HIT1719R2 HIT2098 HIT3109 HIT0140 HIT0589R1 HIT0589M HIT0851 HIT2018 HIT0868 HIT1830 HIT1987 HIT3130 HIT1029 HIT1338 HIT0516 HIT1865 HIT3198 HIT0630 HIT1956 HIT0112 HIT0809 HIT0206 HIT1765 HIT0205 HIT3454 HIT2003 HIT0143R1 HIT1135 HIT1131 HIT1719R1 HIT3722 HIT0866 HIT0532 HIT0143M HIT1506 HIT1866 HIT0088 HIT0090 HIT3615 HIT3624 HIT0887 HIT0952 HIT0401 HIT2126 HIT1889 HIT3397 HIT1968 HIT0555 HIT0542 HIT1925 HIT3315 HIT0310 HIT0886 HIT1396 HIT1625 HIT0312 HIT1697R2 HIT3587 HIT1967 HIT0127 HIT0749 HIT1389 HIT3242 HIT3705 HIT1113 HIT0849 HIT1697M HIT3314 HIT3635 HIT3360 HIT1072 HIT3525 HIT3131M HIT3131R1 HIT3592 HIT3591 HIT0268 HIT0996 HIT3726 HIT0427 HIT2319 HIT1234 HIT3677 HIT1376 HIT3713 HIT3515 HIT2222 HIT1895 HIT1799 HIT0940 HIT3469 HIT0185 HIT2027 HIT1318 HIT0833 HIT1327 HIT1446 HIT0059 HIT1408 HIT0329 HIT1369 HIT3439 HIT0066 HIT1460 HIT0236 HIT1227 HIT1306 HIT1070 HIT1642 HIT1444 HIT3499 HIT0896 HIT1332 HIT1284 HIT1760 HIT0762 HIT1348 HIT1348 HIT0234 HIT3435 HIT0238 HIT1454 HIT0072 HIT1462 HIT3394 HIT1267 HIT1452 HIT1563 HIT1137 HIT1301 HIT1738 HIT1392 HIT0061 HIT1203 HIT0162 HIT1440 HIT3441 HIT3537 HIT1241 HIT0297 HIT0769 HIT0286 HIT1062 HIT0331 HIT1260 HIT0721 HIT0805 HIT1325 HIT0658 HIT0167 HIT0077 HIT1394 HIT1278 HIT1361 HIT1066 HIT1567 HIT1074 HIT3483 HIT3660 HIT3661 HIT1052 HIT3585 HIT0315 HIT0487 HIT0444 HIT3541 HIT0857 HIT2350 HIT0303 HIT1331R1 HIT1331M HIT3630 HIT0892 HIT3117 HIT0225 HIT2840 HIT3702 HIT0265 HIT1397 HIT0633 HIT0782 HIT1788 HIT3179 HIT3633 HIT1820 HIT3627 HIT3302 HIT1496 HIT0823 HIT3227 HIT1522 HIT0928 HIT1347 HIT2119 HIT0485 HIT3329 HIT3100 HIT1436 HIT0754 HIT1381 HIT0627 HIT3279 HIT0563 HIT1245 HIT2475 HIT1947 HIT1404 HIT1951 HIT3052 HIT1225 HIT2968 HIT0095 HIT0150 HIT0450 HIT0448 HIT0424 HIT0864 HIT1521 HIT2999 HIT3274 HIT1882 HIT3601 HIT3054 HIT0792 HIT0519 HIT1558 HIT2577 HIT0829 HIT1189 HIT0494 HIT1617 HIT3725 HIT0649 HIT0114 HIT1188 HIT1450 HIT1489 HIT1745 HIT0613 HIT0592 HIT1134 HIT0539 HIT1922 HIT0757 HIT1594 HIT0547 HIT0084 HIT1655 HIT1674 HIT0944 HIT0537 HIT0620 HIT1651 HIT1597 HIT3304 HIT0712 HIT0566 HIT1298 HIT2939 HIT0697 HIT2980 HIT1027 HIT1492 HIT3322 HIT0305 HIT1469 HIT0776 HIT1418 HIT3631 HIT1144 HIT0954 HIT2056 HIT0406 HIT0405 HIT2171 HIT0404 HIT1736 HIT3720 HIT0199 HIT3519 HIT0988 HIT3710 HIT2547 HIT1905 HIT1945 HIT1466 HIT1628 HIT0370 HIT1904M HIT1541 HIT2076 HIT0625 HIT3598M HIT1163 HIT0467 HIT0830 HIT1704 HIT0117 HIT2546 HIT0028 HIT3505 HIT3509 HIT0105R1 HIT0665 HIT1211 HIT2574A2 HIT1426 HIT1356 HIT0366M HIT1600R3 HIT1612R1 HIT1924R1 HIT1132R1 HIT1845 HIT0326 HIT0001 HIT1498R1 HIT1079R1 HIT3521M HIT3521R1 HIT0668 HIT0932R1 HIT3112 HIT2317 HIT0055 HIT1470R2 HIT1620R5 HIT3598R1 HIT0879 HIT0413 HIT0483 HIT0219 HIT0076 HIT1620M HIT2623R2 HIT0837 HIT0932M HIT3652 HIT0292 HIT1894 HIT1714 HIT1402 HIT0429M HIT1420 HIT0963 HIT0247 HIT1212 HIT1854 HIT0178 HIT0397 HIT1980R1 HIT0808M HIT0930 HIT1600M HIT0152 HIT1470M HIT0032 HIT0474 HIT1022 HIT1903 HIT3549 HIT1693 HIT1829 HIT1932 HIT1680 HIT1385M HIT3658 HIT1498M HIT1768 HIT1969 HIT1346R1 HIT0100 HIT1518M HIT0970 HIT1415 HIT0972 HIT0013 HIT0293 HIT0244 HIT3267 HIT3614 HIT0933 HIT0520R1 HIT1170 HIT1494 HIT0342 HIT2198 HIT3573 HIT0777R1 HIT3664 HIT0820 HIT0655 HIT1606 HIT1600R2 HIT1773 HIT0795 HIT0982R1 HIT0165R1 HIT0365 HIT0838 HIT2164 HIT3659 HIT1620R6 HIT3642 HIT0998 HIT1633 HIT1386 HIT3671 HIT0789 HIT2434 HIT1811 HIT0541 HIT0570 HIT2623R1 HIT2623M HIT2856M HIT0429R1 HIT1913 HIT1353R1 HIT1353M HIT0533 HIT1824 HIT3404M HIT0475 HIT0262 HIT1546 HIT2095 HIT0726 HIT0333 HIT0503M HIT1584 HIT0157 HIT0647 HIT3516 HIT1901 HIT1043 HIT2909 HIT1410 HIT3425 HIT0876 HIT0348 HIT2409R1 HIT0948M HIT1880 HIT1688 HIT3126 HIT1329 HIT0522 HIT0701 HIT2078 HIT1039 HIT0637 HIT0948R1 HIT1904R1 HIT3116M HIT0366R1 HIT1346M HIT0585M HIT3298R1 HIT1321 HIT3513 HIT0320R1 HIT1488 HIT0814R1 HIT2574R3 HIT1600R1 HIT0982M HIT0376 HIT0513 HIT3261 HIT1350 HIT1867 HIT3524 HIT1296 HIT0082 HIT1385R1 HIT0898 HIT2900 HIT3298M HIT3298R3 HIT1470R1 HIT2510 HIT0523 HIT2693 HIT1924M HIT0729 HIT0025 HIT1294 HIT1079M HIT0615R1 HIT0699 HIT1620R3 HIT0320M HIT2615 HIT2409M HIT2029 HIT1518R1 HIT1803 HIT0703R1 HIT1612M HIT0808R1 HIT1152 HIT1428 HIT1095 HIT0703M HIT0925 HIT3555 HIT0683 HIT1723 HIT0372 HIT1577 HIT0814M HIT1963 HIT3116R1 HIT1703 HIT1551 HIT0165M HIT0593 HIT0767 HIT0132 HIT3588 HIT1231 HIT0615M HIT3370 HIT0183 HIT0604 HIT0459 HIT3298R2 HIT0174 HIT1473 HIT1852 HIT0827 HIT3521R2 HIT0615R2 HIT3404R1 HIT0549 HIT1838 HIT0130 HIT3679 HIT1166 HIT2087 HIT0747
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, HOng Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithania, Malaysia, Maurtama, Morocco, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
  • Descripción del producto
    ARIA versions 8.0 and 8.1 || Varian Medical Systems, Palo Alto, CA 94304 || The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA