Class 2 Device Recall Digital Imager, Radiation Therapy

• Date Initiated by Firm: December 19, 2012
• Date Posted: March 10, 2013
• Recall Status: Terminated on July 14, 2021
• Recall Number: Z-0931-2013
• Recall Event ID: 64165
• 510(K)Number: K051932
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
• Code Information: 151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter Ne; Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Linda Wetsel; 770-300-9725
• Manufacturer Reason for Recall: The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
• FDA Determined Cause: Software design
• Action: Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated December 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The IFSN informs the user in the TPS, to give the different volumes different structure names. After importing the patient data set from the TPS, make sure that the structure contours are correct. Users are requested to return the signed acknowledgement. Contact your local Elekta office for questions regarding this notice.
• Quantity in Commerce: 164
• Distribution: Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE