Mobius Medical Systems, LP: Medical Device Recall in 2017 - (Recall #: Z-2100-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 23, 2015

Date Posted: May 24, 2017

Recall Number: Z-2100-2017

Event ID: 77177

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.

Status: Terminated

Product Quantity: 270

Code Information:

Version 1.5.0 and 1.5.2 of the Mobius3D software is affected.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Sweden, Canada, Netherlands, Denmark, Spain, Switzerland, Australia, Austria, Israel, United Kingdom, France

Voluntary or Mandated:

Voluntary: Firm initiated