Class 2 Device Recall RaySearch RayStation 4.7

• Date Initiated by Firm: May 27, 2015
• Date Posted: August 25, 2015
• Recall Status: Terminated on September 22, 2017
• Recall Number: Z-2457-2015
• Recall Event ID: 71414
• 510(K)Number: K141860
• Product Classification: System,planning,radiation therapy treatment - Product Code MUJ
• 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.
• Code Information: software build numbers are 4.7.1.10
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavaegen 9; Stockholm Sweden
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 126 programs
• Distribution: Distributed in CO, IL, MI, NC, OH,TN, and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUJ