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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 Device Recall Elekta Impac Software Sequencer see related information
Date Initiated by Firm February 19, 2010
Date Posted October 28, 2010
Recall Status1 Terminated 3 on March 28, 2011
Recall Number Z-0159-2011
Recall Event ID 55712
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 CA 94086-6076
For Additional Information Contact
408-830-8007
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		 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 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 = MUJ and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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