FDA Device recall Z-0557-2016
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
- FDA Device
- Class II
- terminated
- Published 2016-01-06
On 2016-01-06 the FDA classified a Class II recall of MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery by Elekta, citing incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0557-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-09 |
| Published | 2016-01-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | US |
Product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Reason
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Identifiers
| code_info | Versions 2.50 and higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0557-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.