Elekta HexaPOD evo RT Couch Top: Incorrect Patient Positioning Risk After 6D Workflow
Elekta recalls HexaPOD evo RT Couch Top (HexaPOD evo Module) due to potential incorrect patient positioning after 6D radiation therapy workflows. Affected units have specific serial numbers.
Use caution until it’s fixed
Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.
Contact the company
What happened, in plain English
Elekta is recalling certain HexaPOD evo RT Couch Tops (also called HexaPOD evo Modules) because they may tilt incorrectly after completing a 6D workflow, leading to improper patient positioning during radiation treatments. This could affect treatment accuracy and safety. Read more at govinfonow.com/recall/71065-elekta-hexapod-evo-rt-couch-top-incorrect-patient-positioning-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71065-elekta-hexapod-evo-rt-couch-top-incorrect-patient-positioning-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2535-2018
Cite this page
“Elekta HexaPOD evo RT Couch Top: Incorrect Patient Positioning Risk After 6D Workflow.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71065-elekta-hexapod-evo-rt-couch-top-incorrect-patient-positioning-risk. Based on FDA recall #Z-2535-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2535-2018%22&limit=1).
Why it’s dangerous
After completing a 6D workflow, the HexaPOD evo Module may tilt if moved to the position used for 3D treatments without iGUIDE. This can cause incorrect patient positioning during radiation therapy, potentially affecting treatment accuracy and safety.
Who’s affected
Patients receiving radiation therapy using the recalled HexaPOD evo RT Couch Tops. Medical professionals who operate the system with these specific serial numbers are most at risk.
How to tell if you have this one
Check if your HexaPOD evo RT Couch Top (HexaPOD evo Module) has one of the listed serial numbers. The product is used for radiation therapy patient positioning and has a UDI of 04056719001698.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Serial Number
Verify if your HexaPOD evo RT Couch Top has a serial number from the list provided in the recall notice.
Contact Manufacturer
Reach out to Elekta directly to confirm if your unit is affected and get guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Distribution of the device was made nationwide. There was government distribution but no military distribution. Foreign distribution was made to Canada, Algeria, Argentina, Australia, Austria, Bangladesh,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2535-2018 (May 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2535-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.