Z-2100-2017Class II

Mobius3D

Name: Z-2100-2017 Mobius3D
Creator: Mobius Medical Systems, LP
Published: 2015-02-23
License: https://open.fda.gov/license/

Mobius Medical Systems, LP / initiated 2015-02-23 / Terminated / root cause: software

FDA source

Mobius Medical Systems, LP began a recall of Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose... on 2015-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2100-2017
Classification: Class II
Status: Terminated
Initiated: 2015-02-23
Posted: 2017-05-16
Terminated: 2017-07-10
Recalling firm: Mobius Medical Systems, LP
Product: 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 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: 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 [email protected].
Quantity in commerce: 270
Distribution: Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France
Product codes and lots: Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-16

Product code IYE

K140660Class IIMobius3dMobius Medical Systems, LP / cleared 2014-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)