RT Elements Software revisions of the RT Elements applications have a… — Class II medical device recall Z-1205-2019
Terminated recall by Brainlab AG, reported 2019-05-01, distributed nationwide. There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affe
| Recall number | Z-1205-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2019-03-11 |
| Classified | 2019-04-20 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2021-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CN, CO, DE, DZ, ES, FI, FR, GB, HK, IE, IL, IR, IT, JO, JP, KR, LB, MA, MX, NL, PL, PT, SV, TN, TW, ZA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056481000547, 04056481000554, 04056481006853, 04056481007119, 04056481140380, 04056481140397 |
| Model numbers | 21702A |
Product
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
Reason for recall
There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
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-1205-2019. 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.