Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 24, 2017
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 plann
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 versi…
Mobius Medical Systems, LP recalled Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment… - a moderate-severity action.
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment… was recalled by Mobius Medical Systems, LP in May 24, 2017. Reason: Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization…. Check the official notice for the remedy. Verify recall #Z-2100-2017 with the FDA Devices before acting.
The recall
Mobius Medical Systems, LP issued this moderate-severity FDA Devices recall-Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization….
- Moderate
- severity level
- 270 units
- affected scope
- Class II
- classification
- May 24, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2100-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2100-2017) was formally reported on May 24, 2017, with the manufacturer initiating the action on February 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Mobius Medical Systems, LP is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 270.
The documented reason for this recall is: 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 ver… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
270
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2100-2017 |
| Date reported | May 24, 2017 |
| Date initiated | February 23, 2015 |
| Recalling firm | Mobius Medical Systems, LP |
| Firm location | Houston, TX |
| Affected scope | 270 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2100-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mobius Medical Systems, LP. Units affected: 270.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Moderate. Recall number: Z-2100-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2100-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 24, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.