Elekta, Inc. Recall 88599
Description: MOSAIQ Oncology Information System
Elekta, Inc. Recall 88599 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2591-2021 |
| Event ID | 88599 |
| Event Description | MOSAIQ Oncology Information System |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20211006 |
| Device Code Info | MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367) |
| Center Classification Date | 20210929 |
| Recall Initiation Date | 20210902 |
| Recalling Firm | Elekta, Inc. |
| Initial Notification | Letter |
| Similar To |