Recall Z-0221-2015 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
| Date | Nov 15, 2014 (initiated Nov 3, 2014) |
| Status | Terminated |
| Reason | A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports. |
| Root cause | Software design |
| Action | Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000. |
| Quantity | 15 |
| Distribution | US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Dec 12, 2012 |