Recall Z-2100-2017 ยท IYE Accelerator, Linear, Medical
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 radia
| Date | May 16, 2017 (initiated Feb 23, 2015) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140660 | MOBIUS3D Mobius Medical Systems, LP, Jun 24, 2014 |