Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation the
FDA device recall Z-2100-2017 · posted 2017-05-16 · Terminated
Recall details
- Recalling firm
- Mobius Medical Systems, LP
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 270
- Distribution
- Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
- Date initiated
- 2015-02-23
- Date posted
- 2017-05-16
- Date terminated
- 2017-07-10
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBIUS3D (K140660) | Mobius Medical Systems, LP | 2014-06-24 |