FDA Device recall Z-2100-2017
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy by Mobius Medical Systems, citing 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 versi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2100-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-23 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mobius Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Version 1.5.0 and 1.5.2 of the Mobius3D software is affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2100-2017%22
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