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Impac Medical Systems Inc recalls MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical reco
Recalled July 18, 2012 · FDA recall Z-1944-2012 · Impac Medical Systems
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. · FDA Class II
Units
11 affected sites
Sold at
Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
Description
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.
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
Manufacturer(s)
Impac Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →