Reported May 24, 2017 · Terminated
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation…
Mobius Medical Systems, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mobius Medical Systems, LP · 4615 Southwest Fwy Ste 330 · Houston, TX · 77027-7106
Is this the product you have?
- Mobius3D Product UsageMobius3D 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
- Lot codes and dates
- Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.
- Amount recalled
- 270
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Mobius Medical Systems, LP recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.