Class 2 Device Recall ISOLOC

• Date Initiated by Firm: April 11, 2005
• Date Posted: August 08, 2007
• Recall Status: Terminated on April 19, 2011
• Recall Number: Z-1153-2007
• Recall Event ID: 38361
• 510(K)Number: K904908
• Product Classification: Localization software for radiotherapy - Product Code IYE
• Product: ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.
• Code Information: ISOLOC Software Version 6.0, 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 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
• FDA Determined Cause: Software design
• Action: Software to fix the described problem was written and customers contacted by e-mail on 04/11/2005, that a software patch, titled 04112005, was available to their customers on the firm's internet website.
• Quantity in Commerce: 84
• 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