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

Is my product affected?

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

• UPC 00858164002091

Check against the official notice below — it lists the full affected range.

What happened

Elekta's MOSAIQ Oncology Information System version 2.64 (software builds 2.64 SP9 and higher) has been recalled due to a software error affecting setup fields used in cancer treatment planning and imaging. When a setup field for imaging (CT, kV, MV, or MVCT) is created by copying a treatment field or another setup field, the copied field retains the same isocenter as the original field, which may not be the correct isocenter needed for the imaging procedure when sent to the treatment machine. This issue affects 551 units that were distributed in the United States and numerous countries worldwide.

The record does not specify a remedy for affected consumers or facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 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; Rwan Quantity: 551 units Lot/code info: Software Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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