Devices

Device Recall Integrity

  • Modèle / numéro de série
    Product code 90I--YE, no serial number
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINIA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LAOS, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA SUDAN, SURINAME, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UK, UKRAINE, VENEZUELA, VIETNAM, ZIMBABWE
  • Description du dispositif
    Integrity R1.2
  • Manufacturer
    Elekta Limited
  • 1 Event

Fabricant

Elekta Limited
  • Adresse du fabricant
    Elekta Limited, Fleming Way, Crawley United Kingdom
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Integrity
  • Modèle / numéro de série
    Model 1.1
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
  • Description du dispositif
    Integrity. || Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
  • Manufacturer
    Elekta, Inc.
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.