ELEKTA Digital Accelerator under the following brand names: Elekta… — Class II medical device recall Z-2840-2018
Terminated recall by Elekta, Inc., reported 2018-08-29, distributed nationwide. There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
| Recall number | Z-2840-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2017-12-01 |
| Classified | 2018-08-17 |
| Reported by FDA | 2018-08-29 |
| Terminated | 2019-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, LK, LT, MA, MT, MX, MY, NG, NL, NO, NP, NZ, PA, PE, PH, PK, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,998 |
Product
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Reason for recall
There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
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-2840-2018. 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.