FDA Device recall Z-3017-2017
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy enviro…
- FDA Device
- Class II
- terminated
- Published 2017-08-16
On 2017-08-16 the FDA classified a Class II recall of iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy enviro… by Elekta, citing incorrect PEC values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3017-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-19 |
| Published | 2017-08-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | AK, CT, GA, HI, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA |
Product
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Reason
Incorrect PEC values.
Identifiers
| code_info | Scope; iGUIDE 2.2.0, iGUIDE 2.2.1 |
|---|
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-3017-2017%22
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