Recall Z-1597-2020 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Impac Software
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
| Date | Mar 26, 2020 (initiated Sep 24, 2019) |
| Status | Open, Classified |
| Reason | The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units. |
| Root cause | Software design |
| Action | The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release. |
| Quantity | 3732 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc., Sep 5, 2014 |