Class 2 Device Recall Image guided radiation treatment software.

• Date Initiated by Firm: January 02, 2006
• Date Posted: August 08, 2007
• Recall Status: Terminated on April 19, 2011
• Recall Number: Z-1145-2007
• Recall Event ID: 38319
• 510(K)Number: K904908
• Product Classification: radiation treatment software - Product Code IYE
• Product: Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.
• Code Information: Software version: Isoloc 6.5 and Isoloc 4.5
• Recalling Firm/ Manufacturer: Northwest Medical Physics Equipment Inc; 1910 120th Pl SE, Suite 101; Everett WA 98208
• For Additional Information Contact: Andrew D. Jones; 425-672-2841
• Manufacturer Reason for Recall: Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
• FDA Determined Cause: Software design
• Action: Software to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.
• Quantity in Commerce: 132
• Distribution: Nationwide, Korea, Spain, and UK.
• 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 = IYE