Z-1944-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- June 8, 2012
- Termination Date
- June 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 affected sites
Product Description
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
Reason for Recall
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.
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.
Code Information
Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.