MOSAIQ (UDI 07340201500026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07340201500026), received between Nov 12, 2021 and Dec 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (5 reports).

3 FDA recall records name this device's identifier, 3 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.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THE WRONG 2D MOSAIQ SHIFT FOR BEAMS AT COUCH ANGLES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924913 ↗
• MalfunctionAug 28, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT A HITACHI TREATMENT DOSE DID NOT RECORD IN MOSAIQ.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084569 ↗
• MalfunctionJun 26, 2024Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE WRONG DOSE WAS DISPLAYED WHILE MAKING A PORTAL IMAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613913 ↗
• MalfunctionNov 12, 2021Computer Software Problem; Communication or Transmission Problem; Computer Software Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE MACHINE WENT DOWN DURING THE TREATMENT OF A PATIENT. THE CUSTOMER TRIED TO CLOSE OUT THE PATIENT FROM THE MACHINE, BUT THEY WERE UNABLE TO, AND MANUALLY RECORDED THE DOSE TREATED. ONCE THE MACHINE WAS BACK UP AND RUNNING, THE PATIENT INFORMATION WAS STILL SHOWING, AND THE CUSTOMER HAD NOT ACTUALLY CLOSED OUT THE PATIENT AS THEY ORIGINALLY THOUGHT. WHEN THE CUSTOMER TREATED THE PATIENT, THE PARTIAL TREATMENT WAS RECORDED. THE CUSTOMER ATTEMPTED TO ZERO OUT THE MANUALLY RECORDED MU/DOSE WHICH CORRECTED THE DOSE RECORDING BUT DID NOT FIX THE MU LEFT TO BE TREATED. WHEN THE "TREAT" BUTTON IS CLICKED ON TO SEND THE FIELDS TO THE MACHINE, AN ERROR POPS-UP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802299 ↗
• MalfunctionNov 12, 2021Computer Software Problem; Application Network Problem; Computer Software Problem; Application Network Problem

  THE CUSTOMER REPORTED THAT THE RATM INTERFACE INITIALISATION FAILED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802178 ↗