Company: Mobius Medical Systems, LP
Date of Enforcement Report 5/24/2017
Class lI:
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 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.
Recall Number Z-2100-2017
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..
RECALLING FIRM/MANUFACTURER
Mobius Medical Systems, LP, Houston, TX on 2/23/2015. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
270
DISTRIBUTION
Nationwide and Internationally.
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