MOSAIQ (UDI 00858164002091)Recalls & reported problems
Elekta, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
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 used to plan and record radiation treatments. All of the 112 reports list software problems, such as a dose recorded twice, beams not recorded, or the wrong patient selected from the schedule. The reports include 2 injuries and no deaths. 3 recalls name this device: one covers a malware attack, one covers an incorrect treatment center point after copying fields, and one, still open, covers metric values entered into US-unit fields.
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
- 112
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00858164002091), received between Nov 29, 2016 and May 21, 2026 — classified as 2 injuries, 110 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (112 reports).
3 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
- Apr 20, 2021Terminated
Malware attack
Z-1783-2021 · Root cause: Under Investigation by firm · 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 · FDA record ↗
- Dec 4, 2018Terminated
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
Z-0686-2019 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem112
- Communication or Transmission Problem3
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
- Application Network Problem1
- Compatibility Problem1
- Device Handling Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Insufficient Information50
- No Information29
- No Known Impact Or Consequence To Patient24
- No Consequences Or Impact To Patient16
- No Patient Involvement8
- Radiation Overdose2
- Unintended Radiation Exposure2
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Computer Software Problem
THE CUSTOMER REPORTED THAT IRRADIATION WAS MISTAKENLY DELIVERED USING THE COORDINATES OF AN INCORRECT ISOCENTER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25241820 ↗MalfunctionMar 18, 2026Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ INCORRECTLY RECORDED A DOSE TWICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24629136 ↗MalfunctionNov 15, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED CHART CHECK SHOWING OVERRIDES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20695278 ↗MalfunctionNov 15, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED CHART CHECK SHOWING OVERRIDES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20695267 ↗MalfunctionNov 14, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT AFTER TREATMENT THE RECORDED BEAMS WERE NOT RECORDED IN MOSAIQ.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689617 ↗MalfunctionSep 20, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED A CONCERN THAT THE DOSE MAY NOT HAVE BEEN CALCULATED CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 20265170 ↗MalfunctionSep 20, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A ROUNDING DOWN ISSUE WITH DYNAMIC CONFORMAL ARC.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20264811 ↗MalfunctionJul 5, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT WRONG PATIENT SELECTED FROM SCHEDULE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679583 ↗MalfunctionJul 5, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ANOMALY ON THE MOSAIQ SEQUENCER AGENDA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19679222 ↗MalfunctionJul 1, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT AFTER TREATMENT THE RECORDED BEAMS WERE NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information
MAUDE report 19647020 ↗MalfunctionMar 8, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE TREATMENT COUCH COORDINATES ARE NOT CAPTURED IN MOSAIQ AND ARE NOT MATCHING THE COORDINATES THAT THE THERAPISTS TREATED THE PATIENTS WITH.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18864261 ↗MalfunctionMar 6, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ISOCENTER MISMATCH MESSAGE WHEN SENDING THE CT FIELD FOR ONE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18844253 ↗MalfunctionFeb 2, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT AFTER TREATMENT THE RECORDED BEAMS WERE NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18629738 ↗MalfunctionJan 26, 2024Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT AFTER TREATMENT THE RECORDED BEAMS WERE NOT RECORDED IN MOSAIQ.
Patient problems: Insufficient Information
MAUDE report 18586409 ↗MalfunctionNov 17, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT SHOW THE FULL AMOUNT OF PRESCRIBED MONITOR UNITS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18157721 ↗MalfunctionNov 1, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A MIS-RECORDED TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18045595 ↗MalfunctionOct 5, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT ONLY HALF THE METERSET UNITS (MU) DELIVERED WAS REGISTERED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17875134 ↗MalfunctionJul 14, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN INSTANCE OF INCORRECT DOSE RECORDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17323228 ↗MalfunctionJul 13, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MOSAIQ DID NOT RECORD A DOSE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17314933 ↗MalfunctionJun 30, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED KV PORTAL IMAGES WERE TAKEN BUT DID NOT SHOW IN THE TREATMENT CHART.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17238626 ↗MalfunctionJun 30, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED KV PORTAL IMAGES WERE TAKEN BUT DID NOT SHOW IN THE TREATMENT CHART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17238614 ↗MalfunctionApr 20, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ISSUE WITH TREATMENT FIELD DEFINITION RELATED TO COUCH CAPTURE FUNCTION IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16775727 ↗MalfunctionApr 20, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ISSUE WITH TREATMENT FIELD DEFINITION RELATED TO COUCH CAPTURE FUNCTION IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16775463 ↗MalfunctionMar 23, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT WRONG PATIENT SELECTED FROM SCHEDULE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16596647 ↗MalfunctionMar 23, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT WRONG PATIENT SELECTED FROM SCHEDULE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16596643 ↗
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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.
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