RayStation 3 — Class II medical device recall Z-0679-2019
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2019-01-02, distributed in AZ, CA, CO, CT, DE, FL, GA, HI…. Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, R
| Recall number | Z-0679-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2018-11-12 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2020-04-17 |
| Distributed | AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NY, OH, OR, PA, RI, TN, TX, VA, VT, WA, WI |
| Quantity | 69 |
Product
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Reason for recall
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
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-0679-2019. 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.