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Recall Observatory FDA recall evidence

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

June 08, 2012

Class II

Product summary

Firm
Impac Medical Systems Inc
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

    reason.no_named_rule · v1.0.0

    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.