FDAFebruary 23, 2015device
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 calc...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
mobius medical systems lpmobiusmobius medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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