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U.S. Department of Health and Human Services

Class 2 Device Recall SEQUENCER

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  Class 2 Device Recall SEQUENCER see related information
Date Initiated by Firm September 09, 2011
Date Posted October 17, 2011
Recall Status1 Terminated 3 on March 06, 2012
Recall Number Z-0052-2012
Recall Event ID 59961
510(K)Number K981313  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Impac Medical Systems Sequencer

Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.
Code Information All sites with the configuration of the 4D IEC 1217 source file used for the Varian TrueBEam treatment machine.
Recalling Firm/
Impac Medical Systems Inc
100 Mathilda Pl Fl 5th
Sunnyvale CA 94086-6076
For Additional Information Contact Christopher Ivicevich
Manufacturer Reason
for Recall
Varian reported a problem related to certain collimator rotation values which are incorrect on TrueBeam compared to planned values in Mosaiq.
FDA Determined
Cause 2
Nonconforming Material/Component
Action " Impac Medical Systems Inc., sent an USER NOTICE letter to all affected consignees on September 20, 2011. The letters identified the source characterization error, clinical impact, and final resolution. The letter states that Elekta Support will follow up with each consignee and remotely correct the source characterization. Customers were instructed to sign, date and return the attached Confirmation of Receipt Form by one of the three ways indicated. The letter instructs consignees to distribute this notice to any and all users of IMPAC software that may potentially be affected by the issue. For questions, concerns, and requests for upgrade, email support@impac.com or call. The letter provided consignees with a complete list of contact information..
Quantity in Commerce 11 devices
Distribution Nationwide Distribution (USA) - including the states of: AZ, CA, FL, NJ, NY, NV, TX, VA and WA.
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.