CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report

Mosaiq Oncology Information System recalled by Elekta Solutions Ab

Elekta Solutions AB is recalling Mosaiq Oncology Information System, distributed nationwide in the US. The recall was initiated on 17 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 UDI codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0

Quantity recalled4 systems that contain the affected software.

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-0503-2026
FDA event ID: 97562
Recalling firm: Elekta Solutions AB, Stockholm
Classification: Class II
Status: Ongoing
Recall initiated: 17 Sep 2025
FDA classified: 14 Nov 2025
Reported: 26 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

17 Sep 2025	Recall initiated by company
14 Nov 2025	Classified by FDA	+58 days
26 Nov 2025	Published in enforcement report	+12 days

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

Reason for recall

When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.

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 Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.

Nationwide New Mexico

Questions about this recall

Why was it recalled?

When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.

Which lots are affected?

Software Versions: 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 UDI codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0

Where was it sold?

Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.

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.

Reported	Class	Recall	Company	Reason	Where
20 Oct 2021Device	CLASS II	Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro recalled	Elekta Solutions AB	Device Malfunction	NC, ND

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