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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 March 10, 2011
Date Posted June 24, 2011
Recall Status1 Terminated 3 on September 16, 2011
Recall Number Z-2662-2011
Recall Event ID 58186
510(K)Number K981313  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ

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. It gives the capability to notify users of actions that need to take place prior to treatment, to display reference images for set up purposes and to auto setup the machine to predefined settings.
Code Information MOSAIQ 1.30, 1.60, 2.00, 2.10, and 2.20; including all service packs.
Recalling Firm/
Manufacturer		 Impac Medical Systems Inc
100 Mathilda Pl Fl 5th
Sunnyvale CA 94086-6076
For Additional Information Contact Christopher Ivicevich
408-830-8023
Manufacturer Reason
for Recall		 There's a problem in the database conversion program that is used when upgrading from the Multi-ACC¿S to MOSAIQ or from one version of MOSAIQ to another. If the gantry start angle is incorrect prior to pressing beam-on, the patient will be mistreated.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action The firm, Elekta, sent a "USER NOTICE" to its customers with an attached confirmation of receipt form. The notice describes the product, problem and actions to be taken. The customers were instructed to follow the Interim mitigation instructions noted in the notice -verify the Arc start angle of the Simple ARC with MLC treatment field definition prior to delivery and if the customer identifes a field with an errant gantry start angle, to cease using that plan immediately and consult with the original plan for that field and make the correction to the gantry start angle. In addition, the customers were instructed to complete and return the Confirmation of Receipt via fax to: North America and Asia at 702-992-5002 or Europe and Africa +44 (0)1293 654401, Attn: Elekta OIS Su[pport and/or scan and email to: support@impact.com, europe.support@impact.com or by mail; and distribute this notice to any all users of IMPAC software at their organization who are potentially affected by this issue. For questions or requests for upgrade, email support@impac.com (North America/Asia) or europe.support@impac.com (Europe) or call USA 1-800-488-4672.
Quantity in Commerce 840
Distribution Worldwide distribution: USA (nationwide) 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 and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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