Recall Z-0686-2019— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2018-12-04, terminated 2026-02-23. It names one FDA 510(k) clearance: K141572. 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..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-04
- Terminated
- 2026-02-23
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.