Mobius3D Product Usage: Mobius3D software is used for quality… — Class II medical device recall Z-2100-2017
Terminated recall by Mobius Medical Systems, LP, reported 2017-05-24, distributed nationwide. Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization,
| Recall number | Z-2100-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mobius Medical Systems, LP, Houston, TX, United States |
| Recall initiated | 2015-02-23 |
| Classified | 2017-05-16 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, DK, ES, FR, GB, IL, NL, SE |
| Quantity | 270 |
| Reason classes | software |
Product
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
Reason for recall
Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0) and the prior version (1.4.2), where none should have been expected.
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-2100-2017. 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.