iView GT Electronic Portal Imaging Device, used with radiation therapy treatments.
FDA device recall Z-1436-2010 · posted 2010-04-26 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 121 lots
- Distribution
- Nationwide & Puerto Rico
- Date initiated
- 2009-07-31
- Date posted
- 2010-04-26
- Date terminated
- 2010-12-14
- Location
- Norcross, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW (K981790) | Elekta Oncology Systems, Ltd. | 1998-08-07 |