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
This recall has been terminated (originally issued July 6, 2012).
- Company
- Impac Medical Systems Inc
- Recall Initiated
- June 8, 2012
- Posted
- July 6, 2012
- Terminated
- June 19, 2013
- Recall Number
- Z-1944-2012
- Quantity
- 11 affected sites
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
Root Cause
Software design
Action Taken
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.