| Date Initiated by Firm | February 23, 2015 |
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| Date Posted | May 16, 2017 |
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| Recall Status1 |
Terminated 3 on July 10, 2017 |
| Recall Number | Z-2100-2017 |
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| Recall Event ID |
77177 |
| 510(K)Number | K140660 |
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| Product Classification |
Accelerator, linear, medical - Product Code IYE
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| 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. |
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| 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
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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. |
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FDA Determined
Cause 2 | Software design |
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| 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. |
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| Quantity in Commerce | 270 |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = IYE
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