Mobius3D Product Usage: Mobius3D software is used for recall: Software Issue
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation…
Why was Mobius3D Product Usage: Mobius3D software is used for recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
- Product
- Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation…
- Recalling firm
- Mobius Medical Systems, LP
- Quantity
- 270
- Distribution
- Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)