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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ versions 1.3 and 1.4 SEQUENCER

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  Class 2 Device Recall MOSAIQ versions 1.3 and 1.4 SEQUENCER see related information
Date Initiated by Firm February 14, 2008
Date Posted August 16, 2008
Recall Status1 Terminated 3 on June 24, 2009
Recall Number Z-1515-2008
Recall Event ID 46941
510(K)Number K981313  
Product Classification Radiation Therapy Treatment - Product Code IYE
Product SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA.

Used to facilitate the delivery of defined radiotherapy treatment plans.
Code Information MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens DMIP
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		 Software issue may result in change to intended treatment field, potentially resulting in mistreatment.
FDA Determined
Cause 2		 Software design
Action Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.
Quantity in Commerce 36 units
Distribution Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.
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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