Device product
MOSAIQ Oncology Information System
Z-2591-2021
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 88599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-2591-2021
Official wording
Reason: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Code information: MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Distribution pattern: Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
Derived failure modes
-
Unknown
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.