Class 2 Device Recall Odyssey

• Date Initiated by Firm: November 04, 2010
• Date Posted: December 01, 2011
• Recall Status: Terminated on March 02, 2012
• Recall Number: Z-0345-2012
• Recall Event ID: 59934
• 510(K)Number: K042861
• Product Classification: System, planning, radiation therapy treatment - Product Code MUJ
• Product: Odyssey; ; A radiation treatment planning system
• Code Information: Versions 4.4 through 4.7
• Recalling Firm/ Manufacturer: PerMedics, Inc.; 1425 Victoria Ct; Ste B; San Bernardino CA 92408-2808
• For Additional Information Contact: 909-478-5000 Ext. 234
• Manufacturer Reason for Recall: Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values t
• FDA Determined Cause: Device Design
• Action: PerMedics sent an Odyssey TPS URGENT NOTICE OF CORRECTION letter dated November 4, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Anomaly 1 User Corrective Action: Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations were provided if they planned to use Odyssey RT Ion Plan, DICOM RT Image, and/or RTP Link export: Workaround for the invalid exported table and/or collimator angle errors: If, prior to the software correction, any of these affected file types were exported from Odyssey, manually verify that the table and collimator angles are correct. Additionally, apply appropriate changes to any angles deemed incorrect that were obtained from Odyssey's DICOM RT Ion Plan, DICOM RT Image, and/or RTP Link files. Only those machines with table and/or collimator angles that increase in the clockwise direction will have the incorrect angles. Anomaly 2 User Corrective Action: Install the mandatory new version correcting the software as soon as it is available (see PerMedics Corrective Action below). In the meantime, the following recommendations are provided if the user - Changes the patients scheduled start date prior to the software correction: Workaround for Incorrect Monitor Unit Values when Changing Treatment Start Date: If, prior to the software correction, the user changes the patient's treatment start date on any fully-computed IMRT plan, IMAT plan or plan containing a "Region DVH" prescription, the user should force a full recommendation oft hose patient plans prior to fixing and exporting the plan. The following procedure can be used to force a full re-computation of the plan: - Open the patient's plan worksheet - Change the algorithm type of the plan - Change the algorithm type back to its original value - Close t
• Quantity in Commerce: 15
• Distribution: Worldwide Distribution - USA including NY, GA, CA and the countries of Hungary, Brazil, China, India, Italy, and Mexico
• 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 and Original Applicant = PERMEDICS, INC.