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Class 2 Device Recall Sequencer |
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Date Initiated by Firm |
September 02, 2010 |
Date Posted |
October 18, 2010 |
Recall Status1 |
Terminated 3 on June 24, 2011 |
Recall Number |
Z-0076-2011 |
Recall Event ID |
56736 |
510(K)Number |
K981313
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Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product |
Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA. |
Code Information |
All sequencers for all M/A and MOSAIQ builds.. |
Recalling Firm/ Manufacturer |
Impac Medical Systems Inc 100 Mathilda Pl Fl 5th Sunnyvale CA 94086-6076
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For Additional Information Contact |
408-830-8007
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Manufacturer Reason for Recall |
Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
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FDA Determined Cause 2 |
Software design |
Action |
Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672 |
Quantity in Commerce |
797 units |
Distribution |
Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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