FDA Medical Device Recalls (openFDA)
Mobius Medical Systems, LP: 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.
- Recall number
- Z-2100-2017
- Recalling firm
- Mobius Medical Systems, LP
- 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.
- Status
- Terminated
- Initiated
- 2015-02-23
- Posted
- 2017-05-16
- Terminated
- 2017-07-10
- 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.
- Root cause
- Software design
- Action
- The recalling firm sent an Advisory Notice letter dated February 23, 2015 to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Mobius Medical Systems Customer Support at support@mobiusmed.com.
- Quantity
- 270
- Distribution
- Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
- Lot, serial or model codes
- Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
- 510(k) numbers
- ["K140660"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3008610750
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28