Z-1436-2010

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

Name: Z-1436-2010 iView GT Electronic Portal Imaging Device, used with radiation therapy treatments
Creator: Elekta, Inc.
Published: 2009-07-31
License: https://open.fda.gov/license/

Elekta Limited / initiated 2009-07-31 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of iView GT Electronic Portal Imaging Device, used with radiation therapy treatments on 2009-07-31. The reason FDA records is "Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1436-2010
Status: Terminated
Initiated: 2009-07-31
Posted: 2010-04-26
Terminated: 2010-12-14
Recalling firm: Elekta Limited
Product: iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
Root cause tag: software
FDA 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 in commerce: 121 lots
Distribution: Nationwide & Puerto Rico
Product codes and lots: 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.

Product code IYE

K981790Class IIIview Electronic Portal Imaging Device (Epid) Model Number IvewElekta Oncology Systems, Ltd. / cleared 1998-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)