MEVATRON M2/Primus Mid-Energy Model #01940035 — Class II medical device recall Z-1678-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-04-15, distributed in AL, CA, DE, FL, GA, IA, IL, KY…. Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdo
| Recall number | Z-1678-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-02-18 |
| Classified | 2020-04-07 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2021-02-09 |
| Distributed | AL, CA, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WI, WV, WY |
| Quantity | 1,012 |
| Serial numbers | 2045, 2067, 2125, 2507, 2516, 2596, 2689, 2818, 2855, 2962, 3013, 3089, 3103, 3136, 3296, 3397, 3591, 3629, 3639, 3644, 3702, 3873, 3939, 3986, 4018 and 7 more |
| Model numbers | 01940035 |
Product
MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason for recall
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
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-1678-2020. 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.