Drug recall
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in…
FDA recall event 77177 · Class II · Mobius Medical Systems, LP
Key facts
| Event ID | 77177 |
|---|---|
| Recall numbers | Z-2100-2017 |
| Recalling firm | Mobius Medical Systems, LP |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 23, 2015 |
| Report date | May 24, 2017 |
| Termination date | Jul 10, 2017 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3008610750 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: