Mobius3D Software Recalled for Dose Calculation Defect in Radiation Therapy
Mobius Medical Systems is recalling Mobius3D software versions 1.5.0 and 1.5.2 due to a code defect that may cause dose calculation discrepancies in radiation therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that may lead to dose calculation discrepancies in radiation therapy, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Mobius Medical Systems, LP is recalling 270 units of Mobius3D software, versions 1.5.0 and 1.5.2. This software is used by trained radiation oncology personnel for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally based on read-in treatment plans and external measurements.
The recall is due to a defect in the software code that affects users who perform beam customization. This defect may lead to a discrepancy in dose calculation between version 1.5.0 and the prior version 1.4.2, where no discrepancy should have been expected. The affected units were distributed worldwide, including the United States, Sweden, Canada, the Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, the United Kingdom, and France.
Users of the affected software versions should contact Mobius Medical Systems for instructions on how to resolve the issue. The software is not a treatment planning system and is intended only for use as a quality assurance tool by trained personnel.
The recalled product
- 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…
- Manufacturer
- Mobius Medical Systems, LP
- Hazard
- Affected units
- 270
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
Distribution
Distributed nationwide across the United States.
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