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.
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.
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.
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.
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.
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.
Verify if your HexaPOD evo RT Couch Top has a serial number from the list provided in the recall notice.
Reach out to Elekta directly to confirm if your unit is affected and get guidance on next steps.
After completing a 6D workflow, the HexaPOD evo Module may tilt if moved to the 3D treatment position without iGUIDE, potentially causing incorrect patient positioning during radiation therapy.
Check if your HexaPOD evo RT Couch Top has a serial number listed in the recall notice (the full list is provided in the record).
Contact Elekta directly to confirm if your unit is affected and get guidance on next steps. The recall does not specify a remedy.
We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.
Subject: Recall Z-2535-2018 — Elekta Elekta Hello, I own a Elekta that is covered by recall Z-2535-2018 from Elekta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
