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Class 2 Device Recall XVI R4.5 Xray Volume Imaging System |
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Date Initiated by Firm |
January 26, 2012 |
Date Posted |
February 21, 2012 |
Recall Status1 |
Terminated 3 on April 17, 2012 |
Recall Number |
Z-1066-2012 |
Recall Event ID |
61050 |
510(K)Number |
K100115
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product |
Elekta Synergy XVI 4.5 and R4.6
To be used as part of radiation therapy treatment process. |
Code Information |
152433, 152019, 151176, 152248, 152262, 152454, 105941, 151802, 152427, 151628, 151362, 152207, 151545, 151566, 152271, 152425, 152452, 152491, 151808, 152163, 152331, 151443, 151955, 152585, 152522, 151514, 151791, 151430, 151931. 105984, 151412, 152388, 151616, 151141, 152303, 151892, 151785, 152358, 152223, 152305, 152468, 151260, 152469, 152481, 152601, 152356, 152175, 152365, 152177, 152257, 151952, 152353, 152359, 152362, 152352, 152371, 152370, 151942, 151820, 151770, 151864, 151396, 152448, 151954, 151076, 151309, 152103, 152301, 151634, 151793, 152210, 152211, 151080, 152373, 152222, 152158, 152392, 151684, 152530, 152536, 151168, 151839, 151156, 151155, 151157, 152117, 151710, 152308, 152307, 152504, 151683, 151764, 151885, 152432, 151812, 152549. |
Recalling Firm/ Manufacturer |
Elekta, Inc. 4775 Peachtree Industrial Blvd Bldg 300, #300 Norcross GA 30092-3011
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For Additional Information Contact |
Thomas Valentine 770-670-2548
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Manufacturer Reason for Recall |
If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.
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FDA Determined Cause 2 |
Software design |
Action |
ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
For questions regarding this recall call 770-670-2548 |
Quantity in Commerce |
96 units |
Distribution |
Nationwide Distribution including AR, AZ, CA, CT, FL, 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
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = ELEKTA LTD.
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