TrueBeam 2.5Recalls & reported problems
Varian Medical Systems, Inc. · Class 2
- 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 00899475002004), received between Jun 22, 2018 and Jun 22, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Display/Image” (1 report).
1 other recall cover devices cleared under the same FDA submission (K143224); 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.
Most reported problems
Device problems
- No Display/Image1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2018No Display/Image
DURING TREATMENT, WE EXPERIENCED A COLLIMATOR FAULT. WE ENTERED HOME SCREEN FOR THE LINEAR ACCELERATOR AND REINITIALIZED THE MLC'S. WHEN WE RETURNED TO THE TREATMENT SCREEN, IT DID NOT DISPLAY WHAT WAS TREATED. THE PLAN WAS SENT BACK TO MOSAIQ EMR AND NO DOSE OR TREATMENT PARAMETERS WERE RECORDED. PHYSICS NOTIFIED. PATIENT WAS REMOVED FROM THE TREATMENT ROOM. PHYSICIST WAS ABLE TO REVIEW THE LOG FILE ON THE LINEAR ACCELERATOR AND RETRIEVE THE DATA. PHYSICIST MANUALLY ENTERED THE TREATMENT DATA. PATIENT WAS ABLE TO COMPLETE THE REMAINDER OF HIS TREATMENT. VARIAN NOTIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7629652 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K143224. One submission often covers many models, so check the product and lot details in each record.
- Z-0004-2019 · Aug 20, 2018 · TerminatedTrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provi
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.