CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Mosaiq Oncology Information System recalled by Elekta

Elekta is recalling Mosaiq Oncology Information System with Particle Therapy License (License Kit, distributed nationwide in the US. The recall was initiated on 10 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071

Quantity recalled1

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-1078-2026
FDA event ID: 98116
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Dec 2025
FDA classified: 13 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Medical Software

Timeline

10 Dec 2025	Recall initiated by company
13 Jan 2026	Classified by FDA	+34 days
21 Jan 2026	Published in enforcement report	+8 days

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

Reason for recall

Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice

Product as listed by the FDA

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Where it was distributed

US Nationwide distribution in the state of TX.

Nationwide Texas

Questions about this recall

Is Mosaiq Oncology Information System with Particle Therapy License (License Kit recalled?

Yes. Elekta recalled Mosaiq Oncology Information System with Particle Therapy License (License Kit on 10 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1078-2026.

Why was it recalled?

Which lots are affected?

MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071

Where was it sold?

US Nationwide distribution in the state of TX.

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

More recalls from Elekta

All 122

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Fletcher CT/MR Shielded Applicator Set Intracavitary Remote recalled	Elekta	Other	Nationwide
17 Jun 2026Device	CLASS II	Mosaiq Oncology Information System recalled by Elekta	Elekta	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Leksell Vantage Arc System recalled by Elekta	Elekta	Device Malfunction	28 states

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide