FDA-Device2012-07-18Class II
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
Impac Medical Systems Inc
Hazard
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.
Sold states
Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
Affected count
11 affected sites
Manufactured in
100 Mathilda Place, 5th Floor, Sunnyvale, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2012Don't want to check this manually?
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