Class 2 Device Recall RayStation

• Date Initiated by Firm: February 06, 2014
• Date Posted: March 31, 2014
• Recall Status: Terminated on February 17, 2017
• Recall Number: Z-1308-2014
• Recall Event ID: 67511
• 510(K)Number: K130617
• Product Classification: Radiation Therapy Treatment Planning System - Product Code MUJ
• Product: RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
• Code Information: Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
• FEI Number: 3007774465
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavaegen 9; Stockholm Sweden
• For Additional Information Contact: Freddie Cardel; 877-778-3849
• Manufacturer Reason for Recall: RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
• FDA Determined Cause: Software Design Change
• Action: On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.
• Quantity in Commerce: 19 units (16 units domestically & 3 units internationally)
• Distribution: OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
• 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