FDAFDA · Food and drugs·Recall number Z-1944-2012
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
Published July 18, 2012 · Recall initiated: June 8, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Impac Medical Systems Inc
- Distributor
- 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
- Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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