Class 2 Device Recall Pinnacle3

• Date Initiated by Firm: March 03, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on February 01, 2005
• Recall Number: Z-0913-04
• Recall Event ID: 28478
• Product Classification: System, Planning, Radiation Therapy Treatment - Product Code MUJ
• Product: Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part # 9104-2011A Rev. A
• Code Information: Version 7.0e, Rev. A
• Recalling Firm/ Manufacturer: ADAC Laboratories; 6400 Enterprise Ln Ste 201; Madison WI 53719-1138
• For Additional Information Contact: Randy Vader ; 608-288-6945
• Manufacturer Reason for Recall: A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe.
• FDA Determined Cause: Other
• Action: A notification dated March 3, 2004 was sent to the customers. The notification gave recommendations for avoiding the problem and stated that updated software would be provided when it becomes available. Firm representatives made follow-up telephone calls to the consignees.
• Quantity in Commerce: 55
• Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
• 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.