HexaPOD evo RT Couch Top — Class II medical device recall Z-2535-2018
Terminated recall by Elekta, Inc., reported 2018-08-01, distributed nationwide. Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the positi
| Recall number | Z-2535-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2018-05-16 |
| Classified | 2018-07-24 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IT, JP, KR, MA, MX, MY, NL, NZ, PE, PL, PT, SA, SE, SG, SI, TH, TR, TW, VN, ZA |
| Quantity | 725 devices |
| UPC / GTIN / UDI-DI | 04056719001698 |
| Serial numbers | 02580, 02960, 02961, 02962, 02963, 02964, 02966, 02968, 02969, 02970, 02971, 02972, 02973, 02974, 02976, 02977, 02979, 02981, 02982, 02984, 02985, 02986, 02987, 02988, 02990 and 475 more |
Product
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
Reason for recall
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.
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-2535-2018. 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.