MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system us...
FDA Recall #Z-0686-2019 — Class II — December 4, 2018
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.
Recalling Firm
Elekta, Inc. — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
551 units
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.