Class 2 Device Recall ISOLOC

• Date Initiated by Firm: November 30, 2004
• Date Posted: August 09, 2007
• Recall Status: Terminated on April 19, 2011
• Recall Number: Z-1155-2007
• Recall Event ID: 38366
• 510(K)Number: K904908
• Product Classification: Radiotherapy localization software - Product Code IYE
• Product: ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
• Code Information: ISOLOC Software Version 4.2, Part Number NT-NW-425-520.
• Recalling Firm/ Manufacturer: Northwest Medical Physics Equipment Inc; 1910 120th Pl SE, Suite 101; Everett WA 98208
• For Additional Information Contact: Andrew D. Jones; 425-338-1961
• Manufacturer Reason for Recall: When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
• FDA Determined Cause: Software design
• Action: Software to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.
• Quantity in Commerce: 83
• Distribution: Worldwide, including USA, 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