Recalls / —

—#89788

Product

iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K981790

Affected lot / code info

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.

Why it was recalled

Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern

Nationwide & Puerto Rico

Timeline

Recall initiated

2009-07-31

Posted by FDA

2010-04-26

Terminated

2010-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #89788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.