Events

Recall of Device Recall Elekta SL Series/Precise Digital Accelerator.

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
    54559
  • Event Risk Class
    Class 2
  • Event Number
    Z-1159-2010
  • Event Initiated Date
    2005-10-01
  • Event Date Posted
    2010-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88716
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    Customer reported larger than expected variations in wedge factory with gantry rotation.
  • Action
    Important Notice A280 "Wedge Matching Procedure" (dated 11/18/05) was sent to all effected customers. The Important Notice described the issue, warnings and cautions and corrective instructions/Maintenance to take to eliminate occurrence. Direct questions to your local Elekta Limited representative.

Device

Device Recall Elekta SL Series/Precise Digital Accelerator.
  • Model / Serial
    Model SL15, Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387, 105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; Model SL18, Serial Nos. 105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324, 105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363, 105178, 105233; Model SL25, Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275, 105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137, 105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; Model PRECISE ACC, Serial Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821, 105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731, 105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014, 105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016, 105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593, 105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998, 105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776, 105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573, 105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030, 105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561, 105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555, 105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; Model SYNERGY PLAT, Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116, 151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932, 151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176, 151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074, 151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; Model SL20, Serial Nos. 105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381, 105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351, 105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; Model SL75/5, Serial Nos. 103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099, 103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161, 103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386; Model SL1+, Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519, 105498, 105453, 105492, 105467, 105445, 105452; Model SL1, Serial Nos. 105475, 105521, 105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532; Model SL75/20, Serial Nos. 273, 266, 269, 274
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Canada and Mexico.
  • Product Description
    Elekta SL Series/Precise Digital Accelerator. || The product is used with 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