FDA Device recall Z-0686-2019
MOSAIQ Oncology Information System Version 2.64
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of MOSAIQ Oncology Information System Version 2.64 by Elekta, citing if a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that iso….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0686-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-04 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | n/a |
Product
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Reason
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
Identifiers
| code_info | Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0686-2019%22
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