MOSAIQ Medical Charged-Particle Radiation Therapy System — Class II medical device recall Z-3110-2017
Terminated recall by Elekta, Inc., reported 2017-09-13, distributed nationwide. The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy m
| Recall number | Z-3110-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2017-06-30 |
| Classified | 2017-09-06 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2020-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, LK, LT, MA, MT, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,461 |
Product
MOSAIQ Medical Charged-Particle Radiation Therapy System
Reason for recall
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
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-3110-2017. 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.