Recall Z-2591-2021 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System
| Date | Sep 2, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 31 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183034 | MOSAIQ Oncology Information System Elekta, Inc., Dec 4, 2018 |