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U.S. Department of Health and Human Services

Class 2 Device Recall Mobius 3D

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  Class 2 Device Recall Mobius 3D see related information
Date Initiated by Firm February 23, 2015
Date Posted May 16, 2017
Recall Status1 Terminated 3 on July 10, 2017
Recall Number Z-2100-2017
Recall Event ID 77177
510(K)Number K140660  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
Recalling Firm/
Manufacturer		 Mobius Medical Systems, LP
4615 Southwest Fwy Ste 330
Houston TX 77027-7106
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 270
Distribution Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MOBIUS MEDICAL SYSTEMS, LP
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