Elekta Medical Linear Accelerator 1552093Recalls & reported problems
Elekta Solutions AB · Versa HD™ · Class 2
All models of Elekta Medical Linear Accelerator (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 5
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060191071574), received between Jan 17, 2023 and Aug 26, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 14, 2025Class IIOpen, Classified
Due to a manufacturing issue and electrical grounding of systems.
Z-1164-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 25, 2023Class IIOpen, Classified
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
Z-0445-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 5, 2023Class IIOpen, Classified
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Z-1665-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 28, 2021Class IITerminated
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Z-0115-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Sep 17, 2021Class IITerminated
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Z-0116-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Circuit Failure1
- Computer Software Problem1
- Detachment of Device or Device Component1
- Gas/Air Leak1
- Imprecision1
- Melted1
- Positioning Problem1
- Radiation Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- Unintended Radiation Exposure1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
OtherAug 26, 2026Positioning Problem
The customer asked which tolerances are applied for isocentric couch rotation, Gantry rotation and Collimator rotation during Beam interruption.
Patient problems: Insufficient Information
MAUDE report 50450719 ↗MalfunctionMay 7, 2025Gas/Air Leak; Gas/Air Leak
THE CUSTOMER REPORTED A SF6 LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21974631 ↗InjuryMar 18, 2025Circuit Failure; Circuit Failure
THE CUSTOMER REPORTED THAT WHEN DELIVERING STEP AND SHOOT IMRT BEAMS ON THIS MACHINE, THE BEAM STARTED PRIOR TO THE MLC LEAVES BEING IN THEIR FINAL POSITION.
Patient problems: Unintended Radiation Exposure
MAUDE report 21632534 ↗MalfunctionMar 6, 2025Imprecision; Imprecision
THE CUSTOMER REPORTED THAT THE DOSE DISPLAYED INCORRECTLY DURING THE CALIBRATION PROCESS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21534420 ↗MalfunctionMay 17, 2023Computer Software Problem; Detachment of Device or Device Component; Computer Software Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED A RATTLING SOUND WHEN THE GANTRY ROTATES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16944784 ↗MalfunctionJan 17, 2023Melted; Radiation Output Failure
ADULT MALE NEEDING CHEMORADIATION FOR GLIOBLASTOMA; OUTPATIENT RADIATION ONCOLOGY; UNABLE TO RADIATE- VERSA TREATMENT MACHINE WENT DOWN. A WIRE MELTED INSIDE THE MACHINE, UNABLE TO TREAT PATIENTS. PATIENT WAS TAKEN FROM TREATMENT AREA AND ASKED TO WAIT IN WAITING AREA. VENDOR SERVICE WAS NOTIFIED ALONG WITH PHYSICIST. DETERMINED PART/REPAIR WAS NEEDED. PATIENTS WERE CANCELLED FOR REMAINDER OF DAY. ELEKTA WAS CALLED, FSE NOTIFIED, FSE IS ON HIS WAY FROM (B)(4). PART IS ORDERED. MANUFACTURER RESPONSE FOR ACCELERATOR, LINEAR, MEDICAL, ELEKTA MEDICAL LINEAR ACCELERATOR (PER SITE REPORTER). UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16183471 ↗
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 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
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical2 recalls83 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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