MOSAIQ Oncology Information System
- Company
- Elekta, Inc.
- Recall Initiated
- September 2, 2021
- Recall Number
- Z-2591-2021
- Quantity
- 31
- Firm Location
- Sunnyvale, CA
Reason for Recall
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Distribution
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.
Lot / Code Info
MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Root Cause
Software design
Action Taken
The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.