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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Impac Software Sequencer

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 Class 2 Recall
Elekta Impac Software Sequencer
see related information
Date Posted October 28, 2010
Recall Status1 Terminated on March 28, 2011
Recall Number Z-0159-2011
Recall Event ID 55712
Premarket Notification
510(K) Number
K981313 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.
Code Information Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).
Recalling Firm/
Manufacturer
Impac Medical Systems Inc
100 Mathilda Pl Fl 5th
Sunnyvale, California 94086-6076
Manufacturer Reason
for Recall
Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.
Quantity in Commerce 19 units.
Distribution Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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