RT Elements are applications for radiation treatment planning for use… — Class II medical device recall Z-0648-2016
Terminated recall by Brainlab AG, reported 2016-01-20, distributed nationwide. Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surger
| Recall number | Z-0648-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-11-05 |
| Classified | 2016-01-14 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2017-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CN, DE, ES, FR, GB, HK, IE, IL, IT, JP, KR, MX, PT, TR |
| Quantity | 48 systems |
Product
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. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
Reason for recall
Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0
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-0648-2016. 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.