MOSAIQRecalls & reported problems across all models
Elekta Solutions AB · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one MOSAIQ model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 185
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 7
We found 6 models of MOSAIQ by Elekta Solutions AB in the FDA's device registry (GUDID). Together they are named in 185 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2020 and Sep 14, 2026 — classified as 4 injuries, 179 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (185 reports).
7 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MOSAIQ recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · FDA record ↗
- Sep 2, 2021Open, Classified
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Z-2591-2021 · Root cause: Software design · Recall details · FDA record ↗
- Apr 20, 2021Terminated
Malware attack
Z-1783-2021 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Sep 24, 2019Open, Classified
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Z-1597-2020 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
Most reported MOSAIQ problems
Device problems
- Computer Software Problem185
- Communication or Transmission Problem3
- Use of Device Problem3
- Intermittent Communication Failure2
- Application Network Problem1
- Application Program Problem: Medication Error1
- Device Handling Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information167
- No Clinical Signs, Symptoms or Conditions139
- No Information7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- Unintended Radiation Exposure1
MOSAIQ models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MOSAIQ 3.2Accelerator, Linear, Medical4 recalls25 reports
- MOSAIQAccelerator, Linear, Medical2 recalls83 reports
- MOSAIQAccelerator, Linear, Medical2 recalls60 reports
- MOSAIQAccelerator, Linear, Medical3 recalls5 reports
- MOSAIQAccelerator, Linear, Medical1 recall12 reports
- MOSAIQAccelerator, Linear, Medical1 recall0 reports
Recent MOSAIQ adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
OtherSep 14, 2026Computer Software Problem
The customer reported that the Cone Beam Computed Tomography (CBCT) was taken. However, the system did not record the CBCT as having been completed.
Patient problems: Insufficient Information
MAUDE report 50751377 ↗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 ↗MalfunctionMar 19, 2026Computer Software Problem
THE CUSTOMER REPORTED AN ERROR MESSAGE IN MOSAIQ WHEN OPENING AN RT PLAN, WHEN TWO BEAMS HAVE THE SAME NAME IN THEIR TREATMENT PLANNING SYSTEM.
Patient problems: Insufficient Information
MAUDE report 24636877 ↗MalfunctionFeb 6, 2026Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ IS NOT RECORDING THE DOSE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24276076 ↗MalfunctionJan 29, 2026Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ RECORDED A SESSION INCORRECTLY.
Patient problems: Insufficient Information
MAUDE report 24207126 ↗InjuryJan 20, 2026Computer Software Problem
THE CUSTOMER REPORTED THAT A PATIENT RECEIVED TREATMENT TWICE ON THE SAME ARC.
Patient problems: Insufficient Information
MAUDE report 24113556 ↗MalfunctionDec 11, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A "BEAM ON" HANGING STATUS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23776975 ↗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 ↗MalfunctionSep 5, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN XVI SHIFT DISCREPANCY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22975575 ↗MalfunctionSep 5, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A PROBLEM MERGING CBCT INTO MOSAIQ.
Patient problems: Insufficient Information
MAUDE report 22975543 ↗MalfunctionSep 4, 2025Computer Software Problem; Computer Software Problem
THE ERROR CONSISTED OF THE APPLICATION OF A RADIOTHERAPY SESSION BASED ON THE TREATMENT PLAN OF ANOTHER PATIENT. TECHNICIANS SELECTED THE WRONG PATIENT IN THE MOSAIQ SYSTEM. THEY DID NOT FOLLOW THE SECURITY PROCEDURES OF VERIFYING PATIENT IDENTIFICATION.
Patient problems: Insufficient Information
MAUDE report 22963452 ↗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 ↗MalfunctionAug 15, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN XVI SHIFT DISCREPANCY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22813748 ↗
Other Elekta Solutions AB products
All Elekta Solutions AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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