Z-0686-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2019
- Initiation Date
- December 4, 2018
- Termination Date
- February 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 551 units
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.
Distribution Pattern
Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam
Code Information
Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235