Device 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
Z-1944-2012
Product summary
- Event
- Event 62302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 affected sites
- Official record key
device-enforcement:Z-1944-2012
Official wording
Reason: 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.
Code information: Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
Distribution pattern: Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
Derived failure modes
-
Unknown
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.