PRIMUS HI #04504200 with Digital LINAC Systems Control Console… — Class II medical device recall Z-1680-2020
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-1680-2020 |
|---|---|
| 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 | 230,001 |
| Serial numbers | 3025, 3049, 3241, 3267, 3305, 3361, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3657, 3667, 3679, 3731, 3751, 3832, 3924, 3949, 3979, 4036, 5153, 70-4185 |
Product
PRIMUS HI #04504200 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-1680-2020. 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.