Class 3 Device Recall Desktop Pro Linear Medical Accelerator

• Date Initiated by Firm: November 23, 2006
• Date Posted: February 07, 2007
• Recall Status: Terminated on May 14, 2008
• Recall Number: Z-0421-2007
• Recall Event ID: 36967
• 510(K)Number: K982713
• Product Classification: Linear Medical Accelerator - Product Code IYE
• Product: Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
• Code Information: Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)
• Recalling Firm/ Manufacturer: Elekta, Inc.; 4775 Peachtree Industrial Blvd.; Building 300, Suite 300; Norcross GA 30092-3023
• For Additional Information Contact: Linda Wetsel; 770-300-9725
• Manufacturer Reason for Recall: Unexpected Diaphragm movement when manual field size modifications are not saved.
• FDA Determined Cause: Software design
• Action: Consignees were notified by letter on/about 11/23/2006
• Quantity in Commerce: 37 units
• Distribution: Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
• 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