Mobius Medical Systems, LP
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Mobius Medical Systems, LP makes
Mobius Medical Systems, LP manufactures medical devices for radiation therapy planning and delivery, including systems like the DOSELAB PRO for dose calculation and treatment planning, as well as the Mobius3D and MOBIUS3D for 3D imaging and treatment verification in radiotherapy.
Their portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Doselab Pro Ref K141230
Regimes: 510(k) Registry: 510(k)Mobius3D Ref K153014
Regimes: 510(k) Registry: 510(k)MOBIUS3D Ref K140660
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Mobius Medical Systems, LP, initiated on 2015-02-23. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 23 Feb 2015 Z-2100-2017 Class II Terminated 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.
Full distribution text
- 23 Feb 2015 Z-2100-2017 Class II Terminated 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.
Frequently asked questions
How many devices does Mobius Medical Systems, LP have in the registry?
The registry currently lists 3 devices for Mobius Medical Systems, LP. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mobius Medical Systems, LP's devices?
Among its 3 most recently registered devices, Mobius Medical Systems, LP has devices listed in FDA 510(k) (3 devices).
What risk classes do Mobius Medical Systems, LP's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mobius Medical Systems, LP's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mobius Medical Systems, LP?
FDA recall records list 1 recall initiated by Mobius Medical Systems, LP, the most recent initiated on 23 Feb 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mobius Medical Systems, LP in the registry?
The most recently registered devices listed for Mobius Medical Systems, LP include DOSELAB PRO and Mobius3D.