FDA Device recall Z-1807-2014
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Trac…
- FDA Device
- Class II
- terminated
- Published 2014-06-25
On 2014-06-25 the FDA classified a Class II recall of iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Trac… by Elekta, citing A bug in the software prevents the iGUIDE software from logging off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1807-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-29 |
| Published | 2014-06-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elekta |
| Distribution | US |
Product
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Reason
A bug in the software prevents the iGUIDE software from logging off.
Identifiers
| code_info | Software Versions 2.0.0, 2.0.1 and 2.0.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1807-2014%22
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