MOSAIQ 3.2Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Elekta MOSAIQ 3.2 system is software that coordinates radiation treatment delivery on linear accelerators. The 27 reports mostly describe software problems — communication errors between the machine and MOSAIQ, crashes, and treatment plans that fail to load or deliver the wrong meter set. Four open recalls cite these causes, the most recent in May 2026. Reports dropped from 20 to 5 in the last 12 months, with no deaths or injuries mentioned.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 25
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 4

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07340201500071), received between Aug 9, 2024 and Aug 5, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (25 reports).

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

May 21, 2026Open, Classified
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Z-2406-2026 · Root cause: Software design · FDA record ↗
Dec 10, 2025Open, Classified
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
Z-1078-2026 · Root cause: Software change control · FDA record ↗
Sep 17, 2025Open, Classified
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.
Z-0503-2026 · Root cause: Software design · FDA record ↗
Jan 15, 2025Open, Classified
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Z-1162-2025 · Root cause: Software design · FDA record ↗

Most reported problems

Device problems

Computer Software Problem25
Application Program Problem: Medication Error1
Improper or Incorrect Procedure or Method1

Patient problems

Insufficient Information25
No Clinical Signs, Symptoms or Conditions21

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

OtherAug 5, 2026Computer Software Problem; Improper or Incorrect Procedure or Method
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50138982 ↗
MalfunctionApr 9, 2026Computer Software Problem
THE CUSTOMER ASKED IF IT IS POSSIBLE TO UPDATE A RECORD IN MOSAIQ, FOLLOWING A TREATMENT WHERE MOSAIQ INDICATES THAT THE GANTRY DID NOT START AT 0.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24827261 ↗
MalfunctionNov 14, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A PARTIAL THAT IS RECORDED AS VERIFIED TREATMENT FOLLOWED BY AN ADDITIONAL PARTIAL THAT IS RECORDED MANUALLY LEADS TO INCORRECT METERSET BEING SENT TO MACHINE.
Patient problems: Insufficient Information
MAUDE report 23551981 ↗
MalfunctionOct 24, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A COMPLETION PLAN DELIVERY ERROR.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23377282 ↗
MalfunctionAug 22, 2025Computer Software Problem; Application Program Problem: Medication Error; Computer Software Problem; Application Program Problem: Medication Error
INTERNAL TESTING REVEALED THAT WAVED ORDER SETS ADDED TO REGIMEN FOLDER OF CARE PLAN THAT DO NOT FALL ON CARE PLAN CYCLE DAYS ARE NOT APPENDING.
Patient problems: Insufficient Information
MAUDE report 22872251 ↗
MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22201262 ↗
MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22200956 ↗
MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22200951 ↗
MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22200948 ↗
MalfunctionJun 13, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22200946 ↗
MalfunctionJun 12, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE APPLIED SHIFTS DO NOT DISPLAY IN TREND REVIEW (VALUES ARE ZEROED OUT).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22192187 ↗
MalfunctionJun 11, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22182565 ↗
MalfunctionJun 11, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22182564 ↗
MalfunctionJun 11, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22182563 ↗
MalfunctionJun 9, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22165692 ↗
MalfunctionJun 6, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22157022 ↗
MalfunctionJun 6, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22157006 ↗
MalfunctionJun 2, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE 'ACTUAL' VALUES DISPLAYED IN SITE SETUP DID NOT MATCH WITH THE 'ACTUAL' VALUES DISPLAYED ON INTEGRITY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22122364 ↗
MalfunctionMay 30, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT CRCL VALUES CALCULATED BY THE INTERFACE ARE NOT BEING USED IN DRUG CALCULATIONS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22113817 ↗
MalfunctionMay 23, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22077816 ↗
MalfunctionMay 23, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ CRASHED.
Patient problems: Insufficient Information
MAUDE report 22077805 ↗
MalfunctionMay 16, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A SEQUENCER RESTART INTERRUPTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22034222 ↗
MalfunctionMay 9, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE TREATMENT DOSE WAS NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21991895 ↗
MalfunctionSep 2, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE TREATMENT DOSE WAS NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information
MAUDE report 20118087 ↗
MalfunctionAug 9, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT AN INCORRECT SEQUENCE STARTED FOR TEMPLATE ACQUISITION IN CMM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19948786 ↗

Device details

UDI-DI	`07340201500071`
Brand	MOSAIQ
Model	3.2
Company	Elekta Solutions AB
Product code	IYE · Accelerator, Linear, Medical
Class	Class 2
FDA submission	K223229
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 12, 2025

Device type (GMDN): Patient health record information system application software

An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page