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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle3

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  Class 2 Device Recall Pinnacle3 see related information
Date Initiated by Firm March 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 01, 2005
Recall Number Z-0912-04
Recall Event ID 28478
Product Classification System, Planning, Radiation Therapy Treatment - Product Code MUJ
Product Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG
Code Information Version 6.6c
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 2		 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.
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