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U.S. Department of Health and Human Services

Class 2 Device Recall XVI R4.5 Xray Volume Imaging System

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  Class 2 Device Recall XVI R4.5 Xray Volume Imaging System see related information
Date Initiated by Firm October 14, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on November 03, 2014
Recall Number Z-0320-2012
Recall Event ID 60250
510(K)Number K100115  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Synergy XVI R.4.5 and R4.6

ProducT Usage: To be used as part of radiation therapy treatment process.
Code Information 105984, 151076, 151080, 151141, 151155, 151156, 151157, 151168, 151260, 151362, 151396, 151412, 151442, 151545, 151566, 151616, 151628, 151683, 151684, 151710, 151764, 151785, 151802, 151812, 151839, 151885, 151892, 151931, 151942, 151952, 151954, 151955, 152019, 152117, 152158, 152163, 152177, 152207, 152210, 152211, 152222, 152223, 152248, 152257, 152262, 152271, 152301, 152303, 152305, 152307, 152308, 152331, 152352, 152353, 152356, 152358, 152359, 152362, 152365, 152370, 152371, 152373, 152388, 152392, 152425, 152432, 152433, 152448, 152452, 152454, 152468, 152469, 152481, 152491, 152504, 152522, 152536
Recalling Firm/
Manufacturer
Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer Reason
for Recall
The software did not operate as expected.
FDA Determined
Cause 2
Software design
Action Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative.
Quantity in Commerce 77
Distribution Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico
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 and Original Applicant = ELEKTA LTD.
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