MOSAIQ Oncology Information System
Check against the official notice below — it lists the full affected range.
Elekta, Inc. is recalling the MOSAIQ Oncology Information System (version 2.83 when used with First Data Bank). The software has a defect where a drug strength can be changed and approved during the ordering process, but the saved drug strength reverts back to its original value instead of keeping the updated information. This creates a discrepancy between what was approved and what is actually stored in the system. The recalled systems were distributed to healthcare facilities in 17 U.S. states (California, Colorado, Florida, Idaho, Louisiana, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, and Washington) as well as to Australia, Canada, and the United Kingdom. A total of 31 units were affected.
The recall notice does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
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. Quantity: 31 Lot/code info: MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.