Elekta, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0686-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery

Product Classification:

Class II

Date Initiated: December 4, 2018

Date Posted: January 2, 2019

Recall Number: Z-0686-2019

Event ID: 81705

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.

Status: Terminated

Product Quantity: 551 units

Code Information:

Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235

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

Voluntary or Mandated:

Voluntary: Firm initiated