MOSAIQRecalls & reported problems across all models
Elekta, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 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
- 118
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 4
We found 3 models of MOSAIQ by Elekta, Inc. in the FDA's device registry (GUDID). Together they are named in 118 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2016 and May 21, 2026 — classified as 2 injuries, 116 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (118 reports).
4 FDA recall records name at least one of these models by its device identifier, 2 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.
- Apr 20, 2021Terminated
Malware attack
Z-1783-2021 · Root cause: Under Investigation by firm · names 2 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 ↗
- Dec 13, 2018Open, Classified
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
Z-0821-2019 · Root cause: Software change control · Recall details · 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 · Recall details · FDA record ↗
Most reported MOSAIQ problems
Device problems
- Computer Software Problem118
- 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 Conditions55
- Insufficient Information51
- No Information32
- No Known Impact Or Consequence To Patient27
- No Consequences Or Impact To Patient17
- No Patient Involvement9
- Radiation Overdose2
- Unintended Radiation Exposure2
MOSAIQ models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
Recent MOSAIQ adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Elekta, Inc. products
All Elekta, Inc. 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.
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