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.
This recall has been terminated (originally issued August 25, 2015).
- Recall Initiated
- May 27, 2015
- Posted
- August 25, 2015
- Terminated
- September 22, 2017
- Recall Number
- Z-2457-2015
- Quantity
- 126 programs
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distributed in CO, IL, MI, NC, OH,TN, and WA.
Lot / Code Info
software build numbers are 4.7.1.10
Root Cause
Software design
Action Taken
On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.