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U.S. Department of Health and Human Services

Class 2 Device Recall iView GT

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 Class 2 Device Recall iView GTsee related information
Date Initiated by FirmJuly 31, 2009
Date PostedApril 26, 2010
Recall Status1 Terminated 3 on December 14, 2010
Recall NumberZ-1436-2010
Recall Event ID 55064
510(K)NumberK981790 
Product Classification imaging device - Product Code IYE
ProductiView 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
For Additional Information ContactThomas Valentine
770-670-2548
Manufacturer Reason
for Recall		Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
FDA Determined
Cause 2		Software design
ActionElekta 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 Commerce121 lots
DistributionNationwide & Puerto Rico
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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