AlignRT Plus Horizon cameraRecalls & reported problems
Vision Rt Limited · Horizon camera pod · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05056190500481), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
A PATIENT WAS UNDERGOING RADIOTHERAPY ON AN ELEKTA SYNERGY LINEAR ACCELERATOR. ALIGNRT WAS SET UP TO AUTOMATICALLY HOLD THE BEAM OF THE LINAC IF THE PATIENT MOVED OUT OF PRE-DEFINED TOLERANCES FOR MORE THAN TWO (2) SECONDS. THE PATIENT'S ROLL DELTA MOVED OUT OF TOLERANCE. ALIGNRT STARTED THE 2 SECOND COUNTDOWN TO BEAM HOLD. THE DELTAS SHOWED ON THE SCREEN AND THE OPERATOR MANUALLY HELD THE BEAM AFTER ONE (1) SECOND. THE OPERATOR REPORTED THE MANUAL INTERVENTION TO THE MANUFACTURER AS A BEAM HOLD FAILURE, AS THEY HAD EXPECTED ALIGNRT TO AUTOMATICALLY HOLD THE BEAM AFTER ONE (1) SECOND. THE SAME CENTRE REPORTED A RECURRENCE OF THE INCIDENT ON A DIFFERENT PATIENT THE NEXT DAY ((B)(6) 2021) AND A PREVIOUS INCIDENT THE MONTH BEFORE (NOT PREVIOUSLY REPORTED TO THE MANUFACTURER). THERE WAS NO HARM REPORTED TO THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12156820 ↗
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- 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
- 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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