HexaPOD evo RT System Product Usage: The intended use of the device… — Class II medical device recall Z-2691-2016
Terminated recall by Elekta, Inc., reported 2016-09-07, distributed nationwide. Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not mo
| Recall number | Z-2691-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2016-08-18 |
| Classified | 2016-08-30 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2017-05-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DK, FR, IN, IT, JP |
| Quantity | 13 |
Product
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Reason for recall
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
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-2691-2016. 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.