—#118950

Product

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K963624
Affected lot / code info: 105285, 105445, 105305, 105532, 105366, 105403, 105265, 105492, 105273, 105186, 105494, 105481, 105395, 105326, 105467, 105392, 105204, 105382, 105093, 105521, 105154, 105387, 105228, 105126, 105514, 105359, 105279, 105518, 105528, 105210, 105482, 105213, 105466, 105284, 105544, 105260, 105194, 105195, 105515, 105386, 105199, 105475, 105117, 105325, 105127, 105498, 105233, 105187, 105478, 105261, 105166, 105321, 105369, 105363, 105437, 105119, 151370, 151889, 151177, 152420, 152003, 151693, 105664, 151211, 105480, 105570, 105501, 105652, 105608, 105792, 105570, 152188, 151483, 105491, 105801, 151746, 151248, 151052, 152195, 151562, 152354, 105338, 152142, 105316, 152213, 152272, 152434, 151354, 151711, 151685, 151201, 151200, 105376, 151822, 151821, 152389, 105373, 151610, 151651, 151876, 151937, 152020, 151105, 151633, 105684, 151372, 151244, 152283, 152317, 152509, 152516, 152590, 151023, 105810, 153165, 152097, 152286, 105793, 151670, 151153, 105427, 105733, 105223, 105281, 105689, 151065, 105970, 151344, 151859, 105346, 105748, 105760, 105680, 151383, 151417, 151797, 105446, 105870, 105292, 105737, 105714, 151158, 151172, 152216, 152557, 152581, 105920, 151536, 105988, 151028, 151174, 151597, 105229, 151600, 105724, 105301, 105422, 105308, 105535, 151494, 151518, 151586, 151814, 151894, 151723, 105613, 151914, 105752, 152284, 105394, 105674, 151183, 105525, 105531, 105634, 105993, 105620, 152575, 152011, 105592, 105450, 151921, 105896, 152092, 105314, 151701, 151922, 151852, 105595, 105361, 105850, 105923, 105554, 105867, 105353, 105934, 105807, 151996, 152224, 151452, 152869, 152065, 105677, 151034, 151891, 105538, 105602, 105778, 105765, 105903, 151719, 151909, 152002, 152083, 151930, 105687, 105711, 151316, 151318, 151088, 105833, 105946, 151378, 151212, 151596, 151658, 151837, 151762, 151815, 105669, 105966, 105795, 105978, 152398, 152032, 151280, 151150, 151984, 151682, 151656, 151045, 151231, 105504, 151017, 151115, 105975, 105974, 105600, 105414, 105429, 105937, 105838, 105758, 151140, 151101, 105915, 151196, 105968, 105943, 151005, 151982, 151988, 151718, 105615, 105958, 151020, 105860, 105863, 105712, 151829, 105955, 151125, 151144, 151620, 152050, 105550, 152251, 152261, 153343, 151438, 152234, 151121, 152346, 151974, 151046, 151448, 105290, 151351, 105415, 105640, 151090, 105703, 105869, 151175, 151094, 151775, 151462, 151474, 151874, 105575, 105617, 105777, 151089, 151735, 151050, 105695, 105635, 105720, 105138, 105412, 105710, 105619, 105781, 152201, 105906, 105412, 105412, 105721, 151079, 105787, 151022, 105742, 151331, 105811, 151032, 151096, 151004, 151136, 105802, 105957, 151292, 152148, 151332, 151486, 151415, 105874, 151225, 105814, 151092, 151692, 105412, 105864, 151418, 105990, 151674, 151399, 151698, 151522, 105883, 151479, 151443, 151422, 105555, 151340, 151051, 151696, 151616, 151785, 151515, 151765, 105630, 151675, 105929, 151024, 151538, 151523, 151519, 151016, 151432, 151260, 105593, 151371, 151084, 151098, 151530, 151099, 151558, 151789, 105754, 151847, 105647, 105898, 151256, 151154, 151579, 105563, 151250, 151828, 105586, 151683, 151764, 151664, 151751, 105776, 105445, 151545, 151073, 151435, 151861, 151886, 151848, 151430, 151864, 151885, 105759, 105925, 105932, 151933, 151955, 151014, 105890, 152031, 105806, 151104, 105678, 105879, 105859, 105580, 151229, 105564, 105660, 151960, 151969, 151076, 151931, 151961, 151954, 152192, 152200, 152392, 151258, 151159, 151684, 151388, 151216

Why it was recalled

Customers are resetting the default values outside recommended factory settings.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Elekta, sent an "Important Field Safety Notice (IFSN 200 01 103 073 - Electron Applicator Auto-Tracking Defaults)" released on May 28, 2013 and is in the process of being distributed to all customers. The Notice requests users to please adhere to the instructions and advice given in manuals and system dialogues, which explicitly state that a change to auto-tracking values could compromise compliance with safety standards and can cause increased unwanted radiation dose to the patient. All machines should be checked against the default settings attached. If the actual settings are greater than the default settings, then Elekta's recommendation is that the default settings should b re-applied and all relevant physics checks (e.g. beam uniformity, output factor) performed. If, however, auto-tracking values are increased beyond their factory-set defaults, then electron applicator radiation leakage measurements should also be made to ensue that the system remains compliant to IEC safety. All users of Desktop Pro and Integrity 1.1 software will receive a mandatory upgrade to Integrity 1.2 (released 28-Jan-14. The upgrade path to Integrity 1.2 differs depending on system configurations at each customers site, therefore Elekta has released three separate Important Field Safety Modifications in order to upgrade all customers successfully. Important Field Safety Notice 200 01 501 036 Important Field Safety Modifications 200 02 501 037 Applicable System Configuration Desktop Pro with Fast Tuning Magnetron, New Patient Support System; Important Field Safety Notice 200 01 501 038 Important Field Safety Modification 200 02 501 039 Applicable System Configuration Desktop Pro with Linac Control System MK3i, Fast Tuning Magnetron, New Patient Support System; Important Field Safety Notice 200 01 502 035 Important Field Safety Modification 200 02 502 036 Applicable System Configuration All Integrity 1.1 sites. All users of Integrity 3.1 will receive a man

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2014-03-14
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.