CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

Mosaiq Oncology Information System recalled by Elekta

Elekta is recalling Mosaiq Oncology Information System. The recall was initiated on 4 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Build(s): 2.64 SP9 and higher; UDI (01)00858164002091(10)2.64.235

Quantity recalled551 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0686-2019
FDA event ID: 81705
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 4 Dec 2018
FDA classified: 27 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

4 Dec 2018	Recall initiated by company
27 Dec 2018	Classified by FDA	+23 days
2 Jan 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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