Class 2 Device Recall ISOLOC

• Date Initiated by Firm: April 07, 2006
• Date Posted: August 08, 2007
• Recall Status: Terminated on April 19, 2011
• Recall Number: Z-1146-2007
• Recall Event ID: 38355
• 510(K)Number: K904908
• Product Classification: radiotherapy treatment software - Product Code IYE
• Product: ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
• Code Information: ISOLOC 6.5 version, 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: 425-672-2841
• Manufacturer Reason for Recall: This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
• FDA Determined Cause: Software design
• Action: Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.
• Quantity in Commerce: 141 copies
• Distribution: Customers in 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