Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mobius3D Product Usage: Mobius3D software is used for quality assurance Recalled by Mobius Medical Systems, LP Due to Mobius3D version 1.5.0 contained a defect in software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mobius Medical Systems, LP directly.
Affected Products
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.
Quantity: 270
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mobius Medical Systems, LP
Mobius Medical Systems, LP has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report