MOSAIQ (UDI 00858164002336)Recalls & reported problems
Elekta Solutions AB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00858164002336), received between Nov 26, 2020 and Jan 9, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (12 reports).
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K183034); they may or may not involve this specific model.
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 ↗
Most reported problems
Device problems
- Computer Software Problem12
- Communication or Transmission Problem1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Computer Software Problem; Computer Software Problem
THE CUSTOMER REQUESTED HELP ON HOW TO HANDLE LAG BETWEEN SESSIONS AND DOSE ACCUMULATION IN MOSAIQ MONITORING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21110583 ↗MalfunctionJul 12, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT POSITIONS OF THE BLADES BETWEEN THE MOSAIQ AND MONACO DRRS ARE NOT IDENTICAL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19729041 ↗MalfunctionApr 26, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE TREATMENT COUNT IS INCORRECT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19190839 ↗MalfunctionJan 12, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE IMAGES RECORDED/STORED IN MOSAIQ ARE NOT RELATED TO REFERENCE COMPUTERISED TOMOGRAPHY (CT)/ CONE BEAM COMPUTED TOMOGRAPHY (CBCT).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18501261 ↗MalfunctionSep 7, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT OFFSETS WERE NOT SENT TO THE ACCELERATOR AFTER MATCHING.
Patient problems: Insufficient Information
MAUDE report 17697098 ↗MalfunctionJul 14, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ISSUE WHEN EXCEEDING TABLE TARGET CALCULATED FROM CBCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324122 ↗MalfunctionMay 5, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE IMAGES RECORDED/STORED IN MOSAIQ ARE NOT RELATED TO REFERENCE COMPUTERISED TOMOGRAPHY (CT)/ CONE BEAM COMPUTED TOMOGRAPHY (CBCT).
Patient problems: Insufficient Information
MAUDE report 16874663 ↗MalfunctionApr 27, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT FIELD A1.1 WAS TREATED OUTSIDE OF THE TOLERANCE POSITION. THIS DID NOT PROMPT THE USER TO OVERRIDE THE COUCH POSITION AND NO INDICATOR WAS SHOWN THAT THIS WAS TREATED OUTSIDE OF THE 1.0 TOLERANCE IN MOSAIQ.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16822098 ↗MalfunctionApr 6, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT DURING TREATMENT THERE WAS A BEAM TIMER ERROR. THE BMDM WAS RESET AND THE MODALITY BECAME UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16688271 ↗MalfunctionJun 10, 2022Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED MOSAIQ POTENTIAL TREATMENT WITH HEXAPOD IN THE WRONG POSITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14654359 ↗MalfunctionNov 19, 2021Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT THE SEQ DISCONNECTED FROM LINAC DURING TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12842930 ↗MalfunctionNov 26, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT QUICK NOTES DISPLAY STILL SHOWS STATUS AS, "VOIDED NOTES AS ACTIVE."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10911007 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K183034. One submission often covers many models, so check the product and lot details in each record.
- Z-2591-2021 · Sep 2, 2021 · Open, ClassifiedMOSAIQ Oncology Information System
Other Accelerator, Linear, Medical devices
- LANDAUER microSTAR® ii Dosimetry SystemLandauer, Inc. · Accelerator, Linear, Medical38 recalls0 reports
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical3 recalls112 reports
- Elekta Medical Linear Accelerator 1552093Elekta Solutions AB · Accelerator, linear, medical5 recalls6 reports
- Elekta Medical Linear Accelerator 1552092Elekta Solutions AB · Accelerator, linear, medical5 recalls0 reports
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- Elekta Medical Linear Accelerator 1550358Elekta Solutions AB · Accelerator, linear, medical4 recalls2 reports
- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 recalls0 reports
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