Events

Rappel de Device Recall Integrity 1.1.

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 Elekta, 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
    67574
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1322-2014
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • Date de publication de l'événement
    2014-04-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125742
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
  • Action
    An Important Field Safety Notice (IFSN) has been released and distributed to all customers. Integrity 1.1 Incorrect Static Tolerances for Linac Geometric Axes, 200 01 502 032. The notice explains the issue and that the user should apply the static Tolerance Updater tool to check tolerances and adjust as required. Important Field Safety Modification Digital Accelerator FCO Ref: 200 02 502 031 Integrity R1.1 Static Tolerance Updater Tool was released 03-2013. Elekta has released Integrity version 1.2 which contains the permanent fix for this issue. The permanent solution fixes the error that made the digital accelerator protection functions use the value loaded from the calibration database. The solution now ensures the protection functions use the values the digital accelerator calculates. Important Field Safety Notice 200 01 502 035 has been released to inform customers the solution is available. Important Field Safety Modification 200 02 502 036 will track the installation of the software by Elekta service engineers.

Device

Device Recall Integrity 1.1.
  • Modèle / numéro de série
    152718, 152003, 152007, 151963, 152081, 151693, 152131, 152318, 105792, 105570, 152778, 151052, 152363, 152472, 152195, 153022, 152689, 152640, 152642, 152663, 152680, 152782, 152796, 152829, 152862, 152962, 153030, 153125, 153244, 153270, 153211, 153296, 152834, 152596, 151354, 151353, 152664, 151200, 151823, 151822, 151610, 152026, 152027, 152692, 151276, 152856, 151106, 152877, 152986, 152810, 105935, 153105, 153069, 151023, 152914, 151975, 151240, 151239, 153135, 105810, 153145, 153129, 151182, 151650, 152886, 151850, 152831, 153132, 151343, 153063, 105985, 152832, 152845, 152837, 152863, 152859, 152776, 152857, 152866, 152876, 152820, 152870, 152884, 152865, 152872, 152909, 152910, 152911, 152918, 152934, 152961, 152966, 153009, 153041, 153026, 153078, 153079, 153083, 153070, 153066, 153027, 153154, 153157, 153159, 153165, 153131, 153352, 152675, 152737, 152299, 152403, 152676, 151670, 152252, 151153, 151482, 151296, 152068, 152286, 152097, 151554, 151768, 151853, 151854, 151786, 151495, 151787, 153099, 152935, 151865, 151466, 105920, 152521, 151536, 151263, 105988, 151028, 151058, 152719, 151174, 151597, 152645, 152650, 152647, 105755, 152743, 151857, 151921, 105896, 151986, 152855, 152092, 151006, 151277, 105314, 105919, 152746, 152770, 105901, 151635, 152575, 152627, 151701, 151922, 151852, 152422, 152309, 152498, 152628, 152706, 152616, 105850, 152014, 151688, 151638, 152721, 153234, 152816, 105554, 105987, 151452, 151166, 152913, 151740, 152042, 152904, 152254, 152753, 152554, 152591, 152644, 152607, 152648, 152687, 152714, 152899, 152739, 152672, 152900, 152952, 152977, 153080, 153169, 153183, 152908, 153349, 153325, 152702, 152869, 152724, 151529, 152840, 152841, 151442, 151445, 151612, 151613, 151756, 105677, 151755, 151189, 151034, 151652, 152757, 105893, 105892, 152945, 151060, 105711, 105997. 151324, 151316, 151318, 151385, 152873, 151660, 152734, 152646, 152682, 151087, 151088, 105833, 152613, 152958, 105946, 151117, 151308, 151108, 151280, 151912, 152106, 152157, 152294, 152637, 152624, 152667, 152727, 152726, 152750, 152893, 152953, 151132, 151150, 151879, 151583, 152595, 152733, 153087, 152975, 153310, 153229, 152738, 152735, 152785, 152797, 152947, 153327, 152907, 153291, 153290, 152677, 152674, 151112, 105937, 151349, 105838, 105758, 105927, 151045, 151314, 151553, 151140, 151101, 105995, 105915, 151405, 152638, 152325, 152457, 152512, 151196, 151368, 152118, 152119, 105968, 151040, 105912, 151247, 105943, 151005, 105948, 151341, 151898, 151703, 151982, 152161, 151718, 153059, 151297, 151278, 151020, 105928, 152603, 153084, 152942, 151829, 151284, 152298, 151449, 151144, 151602, 152708, 152713, 152605, 152606, 152614, 152611, 152629, 152679, 152799, 152880, 152928, 152920, 152336, 153343, 153348, 152101, 151669, 151237, 151121, 153205, 151897, 105415, 152793, 105640, 105703, 105869, 151175, 151066, 151233, 152060, 151503, 152190, 153333, 152795, 151089, 152660, 152538, 152827, 152848, 152442, 152846, 152723, 152921, 151119, 152769, 152968, 152143, 152720, 151497, 151197, 151420, 105721, 151079, 105787, 105685, 151511, 151022, 105743, 105742, 151249, 151042, 105786, 151516, 151109, 151331, 151524, 152592, 151255, 105813, 151556, 151526, 105811, 151032, 151581, 151243, 151492, 152070, 151096, 151004, 151136, 105797, 105802, 105957, 105789, 151292, 151425, 151291, 152148, 151332, 151333, 151486, 151415, 151573, 151528, 151487, 151527, 151572, 151414, 105874, 151225, 152653, 105814, 151092, 151047, 151706, 151691, 151692, 151934, 151945, 151946, 153190, 151127, 105412, 152030, 152168, 152396, 152654, 151749, 152891, 152878, 152858, 105894, 151033, 151258, 151168, 151159, 151228, 152760, 151791, 152522, 151391, 151216, 151539, 151611, 151696, 151867, 152965, 151325, 152220, 151785, 152217, 151388, 151394, 151892, 152043, 151793, 151684, 152223, 152303, 152358, 151683, 152652, 152659, 152703, 151672, 152767, 152777, 152783, 152784, 152787, 152798, 152881, 151710, 153045, 152929, 153137.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
  • Description du dispositif
    Integrity 1.1. || Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Adresse du fabricant
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA