Events

Recall of Device Recall The Elekta Synergy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elekta, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58874
  • Event Risk Class
    Class 2
  • Event Number
    Z-3079-2011
  • Event Initiated Date
    2011-05-06
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100456
  • Notes / Alerts
    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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    A small number of the modular reverse diodes (d1a), a component in the equipment room of the elekta linear accelerator, have ruptured.
  • Action
    ELEKTA sent an IMPORTANT NOTICE (FCO 20000103022), dated May 6, 2011. The notice identified the product, the problem, and the aciton to be taken by the customer. Elekta recommended that service personnel always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. Elekta also recommended that users make sure that the modulator cover is installed when the digital accelerator is in operation. Elekta will release a Field Change Order when a corrective action is identified.

Device

Device Recall The Elekta Synergy System
  • Model / Serial
    151855, 151340, 151587, 152246, 151694, 105864, 105932, 105559, 151574, 152397, 151803, 151875, 151521, 151965, 151504, 151159, 105941, 151418, 151538, 105555, 151728, 151729, 151399, 105809, 151802, 151421, 105723, 105803, 151362, 151545, 151628, 151566, 152271, 151736, 151700, 151866, 151698, 151699, 151517, 151539, 151636, 151695, 151696, 151981, 105837, 151811, 105584, 151568, 151390, 151258, 151360, 151328, 105590, 151167, 151584, 151317, 151522, 105925, 151055, 151808, 151367, 151769, 151969, 151801, 151977, 105894, 151033, 151391, 151708, 152043, 151267, 151809, 152205, 152019, 151507, 105883, 105914, 151238, 151640, 152163, 151623, 151627, 151443, 151479, 152200, 152192, 151933, 152126, 152115, 152116, 151422, 152123, 151954, 105992, 105950, 151955, 152365, 151014, 151722, 151724, 151779, 151051, 151632, 105644, 152091, 105960, 151810, 151467, 151678, 151514, 151791, 152176, 152064, 151962, 151848, 151849, 151173, 151216, 151430, 151931, 105567, 105744, 105984, 151412, 151616, 151867, 151141, 151228, 152177, 151433, 151611, 152008, 105728, 151151, 105561, 151714, 105646, 152023, 105773, 105587, 105890, 151653, 151785, 151892, 152223, 152352, 152353, 152359, 152362, 151763, 151076, 151515, 105828, 151704, 151765, 151325, 151861, 151035, 151059, 105630, 151675, 105591, 105929, 151024, 151860, 152051, 152031, 105868, 105949, 151260, 151709, 151029, 105770, 105776, 105846, 105895, 151886, 151956, 151812, 151523, 105568, 105936, 105806, 151519, 152175, 152232, 152257, 151952, 151689, 151410, 151084, 105593, 151305, 151371, 105969, 151016, 151774, 152217, 152220, 151435, 105926, 151734, 105872, 151530, 105636, 151626, 151842, 151942, 151432, 151783, 151567, 151598, 151601, 151989, 151958, 151959, 151960, 151821, 151820, 105676, 151319, 151557, 151558, 151411, 151423, 105829, 105844, 151380, 151770, 151864, 105666, 151760, 105902, 105998, 105637, 151073, 151253, 151269, 151396, 151104, 105678, 105879, 105727, 105731, 105782, 105841, 151093, 151110, 151363, 151369, 151705, 152154, 151782, 151098, 151099, 151789, 105649, 151309, 152103, 152301, 151847, 105754, 105982, 151160, 151634, 151684, 151793, 151388, 151394, 105859, 151387, 151978, 152210, 152211, 151080, 152248, 151398, 152222, 151540, 151015, 152214, 151446, 105580, 151143, 152158, 151301, 152392, 105647, 105699, 105898, 151441, 105660, 151038, 151229, 105564, 105565, 152364, 105886, 151256, 151154, 151168, 151178, 151839, 151537, 151155, 151156, 151157, 151491, 105910, 152117, 105853, 105854, 105856, 151759, 151053, 151359, 105624, 151710, 152079, 152080, 105563, 105648, 105655, 151585, 105882, 151326, 151327, 151130, 151250, 151828, 151881, 151882, 105796, 105812, 151245, 152307, 152308, 152331, 105612, 151416, 151805, 152098, 151579, 151961, 105586, 151683, 151764, 105621, 151664, 151953, 105990, 151674, 105657, 101751, 152036, 151885, 105610, 151134, 151266, 151672, 151074, 151008, 151595, 152174, 151259, 151352, 152207, 151298
  • Product Classification
    Radiology Devices
  • Distribution
    Nationwide and Puerto Rico
  • Product Description
    Elekta Synergy || The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA