Device Recall Integrity

  • Model / Serial
    Model 1.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Integrity. || Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter Ne, Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product code 90I--YE, no serial number
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    Integrity R1.2
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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