COHERENCE Oncologist — Class II medical device recall Z-1346-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-03-04, distributed in CA, FL, GA, IA, MA, MI, NE, NJ…. A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the i
| Recall number | Z-1346-2020 |
|---|---|
| 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 | 2020-01-16 |
| Classified | 2020-02-21 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2021-01-04 |
| Distributed | CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV |
| Model numbers | 07333680, 07351898 |
Product
COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Reason for recall
A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.
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-1346-2020. 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.