Class 2 Device Recall RayStation

• Date Initiated by Firm: December 06, 2011
• Date Posted: March 26, 2012
• Recall Status: Terminated on May 11, 2012
• Recall Number: Z-1317-2012
• Recall Event ID: 61269
• 510(K)Number: K100552
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com Designed for treatment planning and analysis of radiation therapy.
• Code Information: Software version and build number is 2.0.0.15. Model number RayStation 2.0
• FEI Number: 3007774465
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavaegen 9; Stockholm Sweden
• Manufacturer Reason for Recall: An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
• FDA Determined Cause: Device Design
• Action: The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or freddie.cardel@raysearchlabs.com; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or niclas.borglund@raysearchlabs.com
• Quantity in Commerce: 21 units (16 domestically and 5 internationally)
• Distribution: Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
• 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