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Recall Observatory FDA recall evidence

Device product

RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

Z-2457-2015

May 27, 2015

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 71414
Status
Terminated
Classification
Class II
Quantity
126 programs
Official record key
device-enforcement:Z-2457-2015

Official wording

Reason: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.

Code information: software build numbers are 4.7.1.10

Distribution pattern: Distributed in CO, IL, MI, NC, OH,TN, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.