Elekta Medical Linear Accelerator — Class II medical device recall Z-0116-2022
Terminated recall by Elekta, Inc., reported 2021-10-20, distributed nationwide. There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the mach
| Recall number | Z-0116-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2021-09-17 |
| Classified | 2021-10-14 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, 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, LB, LK, LT, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 4,405 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05060191071017, 05060191071512, 05060191071529, 05060191071543, 05060191071550, 05060191071574, 05060191071581 |
| Model numbers | 0511, 0601, 0621, 2121, 2201 |
Product
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
Reason for recall
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
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-0116-2022. 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.