iGUIDE System — Class II medical device recall Z-1705-2016
Terminated recall by Elekta, Inc., reported 2016-06-01, distributed in IL, LA. If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*STAR
| Recall number | Z-1705-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-05-12 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2021-07-16 |
| Distributed | IL, LA |
| Countries outside the US | AT, AU, DE, DK, FR, IN, JP |
| Quantity | 20 |
Product
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1705-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.