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Class 2 Device Recall iView GT |
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Date Initiated by Firm |
July 31, 2009 |
Date Posted |
April 26, 2010 |
Recall Status1 |
Terminated 3 on December 14, 2010 |
Recall Number |
Z-1436-2010 |
Recall Event ID |
55064 |
510(K)Number |
K981790
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Product Classification |
imaging device - Product Code IYE
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Product |
iView GT Electronic Portal Imaging Device, used with radiation therapy treatments. |
Code Information |
131039, 131053, 131065, 131079, 131084, 131116, 131130, 131137, 131139, 131157, 131163, 131239, 131240, 131248, 131278, 131285, 131289, 131307, 131308, 131315, 131321, 131326, 131355, 131358, 131360, 131368, 131385, 131387, 131426, 131427, 131429, 131513, 131550, 131578, 131583, 131593, 131638, 131645, 131648, 131691, 131705, 131708, 131720, 131756, 131760, 131778, 131800, 131809, 131815, 131818, 131819, 131822, 131842, 131852, 131855, 131870, 131873, 131874, 131875, 131876, 131878, 131891, 131895, 131898, 131899, 131902, 131910, 131926, 131927, 131928, 131931, 131937, 131943, 131958, 131964, 131975, 131976, 131978, 131980, 131985, 131996, 131998, 131999, 132002, 132003, 132004, 132010, 132014, 132019, 132024, 132025, 132026, 132031, 132039, 132042, 132043, 132045, 132058, 132061, 132072, 132078, 132079, 132080, 132083, 132084, 132085, 132090, 132091, 132092, 132101, 132103, 132105, 132111, 132114, 132120, 132122, 132126, 132127, 132151, 132164, and 132198. |
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 |
Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
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FDA Determined Cause 2 |
Software design |
Action |
Elekta sent IMPORTANT NOTICE number A329, dated 31 July, 2009 to all customers. This corresponds with Field Change Order - Documentation 764 00 551 060 "An Important Notice (A329) has been issued for replacement of iViewGT R3.4 Service Pack 2 (SP2) installation CD". Mandatory Field Change Order 764 00 551 059 "Replacement of iViewGT R3.4 installer disk"supersedes FCO 764 00 551 053. |
Quantity in Commerce |
121 lots |
Distribution |
Nationwide & 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 ONCOLOGY SYSTEMS, LTD.
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