Device product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Z-2063-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 71573
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74 Total (45 US)
- Official record key
device-enforcement:Z-2063-2015
Official wording
Reason: A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Code information: Software Version 2.41 and higher
Distribution pattern: Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
Derived failure modes
-
Unknown
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.