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Terminated

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

FDA Recall Z-1436-2010 · Posted 2010-04-26

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-07-31
Date Terminated2010-12-14
Product Quantity121 lots

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide & Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981790IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEWElekta Oncology Systems, Ltd. · 1998-08-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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