FDA Device recall Z-2230-2019
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- FDA Device
- Class II
- terminated
- Published 2019-08-21
On 2019-08-21 the FDA classified a Class II recall of iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 by Elekta, citing potential for iGUIDE to incorrectly monitor the 3D position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2230-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-19 |
| Published | 2019-08-21 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | US |
Product
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Reason
Potential for iGUIDE to incorrectly monitor the 3D position.
Identifiers
| code_info | Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742;…Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2019%22
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