Z-2100-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- February 23, 2015
- Termination Date
- July 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
Code Information
Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.