FDA Medical Device Recalls (openFDA)
Elekta, Inc.: iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
- Recall number
- Z-1436-2010
- Recalling firm
- Elekta, Inc.
- Product
- iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
- Status
- Terminated
- Initiated
- 2009-07-31
- Posted
- 2010-04-26
- Terminated
- 2010-12-14
- Reason
- Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
- Root cause
- 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
- 121 lots
- Distribution
- Nationwide & Puerto Rico
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K981790"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28