FDA Device recall Z-1705-2016
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment by Elekta, citing if by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1705-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-12 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | IL, LA |
Product
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Reason
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
Identifiers
| code_info | Software iGUIDE 2.1 and 2.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1705-2016%22
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