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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ Oncology Information Systems

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  Class 2 Device Recall MOSAIQ Oncology Information Systems see related information
Date Initiated by Firm June 08, 2012
Date Posted July 06, 2012
Recall Status1 Terminated 3 on June 19, 2013
Recall Number Z-1944-2012
Recall Event ID 62302
510(K)Number K120067  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines.

An image enabled electronic medical record system used for oncology workflow management.

Manufactured by:
Impac Medical Systems
100 Mathilda Place, 5th floor
Sunnyvale, Ca 94086
Code Information Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
Recalling Firm/
Manufacturer		 Impac Medical Systems Inc
100 Mathilda Place
5th Floor
Sunnyvale CA 94086-6076
For Additional Information Contact Chris Ivicevich
408-830-8023
Manufacturer Reason
for Recall		 Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.
FDA Determined
Cause 2		 Software design
Action A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.
Quantity in Commerce 11 affected sites
Distribution Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
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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