Class 2 Device Recall RayStation

• Date Initiated by Firm: October 23, 2013
• Date Posted: November 14, 2013
• Recall Status: Terminated on February 17, 2017
• Recall Number: Z-0281-2014
• Recall Event ID: 66600
• 510(K)Number: K120387 K130617
• Product Classification: Radiation Therapy Treament Planning System - Product Code MUJ
• Product: Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
• Code Information: Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
• Recalling Firm/ Manufacturer: RAYSEARCH LABORATORIES AB; Sveavaegen 9; Stockholm Sweden
• Manufacturer Reason for Recall: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
• FDA Determined Cause: Software design
• Action: Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
• Quantity in Commerce: 195 units domestically
• Distribution: US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
• 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