MOSAIQ (UDI 00858164002367)Recalls & reported problems
Elekta Solutions AB · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Elekta MOSAIQ system is software for managing radiotherapy treatment records. Most of the 82 reports describe software errors, such as doses or sessions not being recorded correctly. The reports include 4 injuries and no deaths, and reports dropped from 24 in the previous 12 months to 4 in the last 12 months. There are 2 recalls: one open over a saved drug strength reverting to its original value, and one closed over a malware attack.
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
- 83
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00858164002367), received between Dec 3, 2021 and Sep 14, 2026 — classified as 4 injuries, 78 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (83 reports).
2 FDA recall records name this device's identifier, 1 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
Recalls naming this device
- 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 · FDA record ↗
- Apr 20, 2021Terminated
Malware attack
Z-1783-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem83
- Device Handling Problem1
- Intermittent Communication Failure1
- Use of Device Problem1
Patient problems
- Insufficient Information75
- No Clinical Signs, Symptoms or Conditions56
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 83 reports, 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 ↗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 ↗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 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 ↗MalfunctionAug 6, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE XVI TREATMENT CENTER LOOKED WRONG.
Patient problems: Insufficient Information
MAUDE report 22724488 ↗InjuryJul 25, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED WITH AN INCORRECT ISOCENTER IN THE Y-DIRECTION.
Patient problems: Insufficient Information
MAUDE report 22607379 ↗MalfunctionJul 3, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A TREATMENT FIELD DID NOT RECORD.
Patient problems: Insufficient Information
MAUDE report 22394442 ↗MalfunctionJun 18, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A SESSION WAS NOT COUNTED FOR ONE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22279163 ↗MalfunctionJun 18, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ SENT A DRUG ORDER TO AN INCORRECT ROUTE VIA THE ESI INTERFACE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22272162 ↗MalfunctionJun 4, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A PROBLEM SENDING TABLE PARAMETERS FROM MONACO TO MOSAIQ.
Patient problems: Insufficient Information
MAUDE report 22140573 ↗MalfunctionMay 1, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT NOT ALL FIELDS RECORDED IN MOSAIQ - PATIENT (B)(6).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21941110 ↗MalfunctionMay 1, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT NOT ALL FIELDS RECORDED IN (B)(6) - PATIENT B.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21941055 ↗MalfunctionApr 17, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE MLC (MULTI-LEAF COLLIMATOR) TREATMENT POSITIONS DO NOT MATCH THE PRESCRIBED TREATMENT POSITIONS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21857968 ↗MalfunctionApr 2, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REQUESTED FOR SUPPORT FOR MANUAL INSERTION OF A TREATMENT SESSION WHICH WAS NOT RECORDED DUE TO A HOSPITAL POWER BLACKOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750085 ↗MalfunctionFeb 6, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTS THAT THE SAME FIELD WAS DELIVERED TWICE.
Patient problems: Insufficient Information
MAUDE report 21322069 ↗MalfunctionFeb 6, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER HAS QUESTIONS ABOUT THE MU/DEGREE VALUE IN THE FIELD TREATMENT DEFINITION SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21320447 ↗MalfunctionJan 17, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A FIELD DELIVERY WAS NOT RECORDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21178674 ↗MalfunctionJan 17, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A FIELD DELIVERY WAS NOT RECORDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21178669 ↗MalfunctionJan 15, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT CBCT (CONE BEAM COMPUTED TOMOGRAPHY) WAS NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21157749 ↗MalfunctionJan 15, 2025Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED PARTIAL TREATMENT PLAN NOT LOADING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21157372 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.