MOSAIQ (UDI 00858164002220)Recalls & reported problems
Elekta, Inc. · Class 2
All models of MOSAIQ (3)
Data updated Oct 16, 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.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00858164002220), received between Mar 27, 2019 and Dec 10, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (6 reports).
1 FDA recall record 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem6
Patient problems
- No Information3
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2021Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISCREPANCY BETWEEN MLC PRESCRIPTION AND MLC TREATMENT POSITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12975890 ↗MalfunctionJan 31, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE MONITORED VOLUME DISPLAYED INCORRECTLY DURING MOTION MONITORING.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 9652138 ↗MalfunctionOct 31, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE GANTRY ANGLE WAS DIFFERENT THAN THE ONE DEFINED IN THE SETUP FIELD. BASED UPON THE AVAILABLE INFORMATION THE CLINICIAN CONSIDERS SERIOUS MISTREATMENT TO THE PATIENT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 9261079 ↗MalfunctionOct 31, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE GANTRY ANGLE WAS DIFFERENT THAN THE ONE DEFINED IN THE SETUP FIELD. BASED UPON THE AVAILABLE INFORMATION THE CLINICIAN CONSIDERS SERIOUS MISTREATMENT TO THE PATIENT.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 9260498 ↗MalfunctionMay 30, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY HAD AN ISSUE WITH A PATIENT WHO MOVED THE COUCH DUE TO GRIPPING ONTO THE ENDS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8654227 ↗MalfunctionMar 27, 2019Computer Software Problem; Computer Software Problem
DURING ELEKTA INTERNAL INVESTIGATIONS IT WAS FOUND THAT PREGNANCY AND IMPLANT STATUS DO NOT HAVE ANY RATE RANGE CHECKING.
Patient problems: No Patient Involvement
MAUDE report 8455035 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 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