Elekta Medical Linear AcceleratorRecalls & reported problems across all models

We found 8 models of Elekta Medical Linear Accelerator by Elekta Solutions AB in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jan 17, 2023 and Aug 26, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Grounding Malfunction” (2 reports).

7 FDA recall records name at least one of these models by its device identifier, 5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Elekta Medical Linear Accelerator recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 14, 2025Open, Classified

   Due to a manufacturing issue and electrical grounding of systems.

   Z-1164-2026 · Root cause: Process control · names 8 of these models · Recall details · FDA record ↗

2. Oct 25, 2023Open, 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-0446-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

3. Oct 25, 2023Open, 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 · names 2 of these models · Recall details · FDA record ↗

4. Oct 25, 2023Open, 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-0443-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

5. May 5, 2023Open, 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 · names 6 of these models · Recall details · FDA record ↗

6. Sep 28, 2021Terminated

   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 · names 3 of these models · Recall details · FDA record ↗

7. Sep 17, 2021Terminated

   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 · names 6 of these models · Recall details · FDA record ↗

Most reported Elekta Medical Linear Accelerator problems

Elekta Medical Linear Accelerator models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elekta Medical Linear Accelerator 1552093

  Accelerator, linear, medical
  5 recalls6 reports
• Elekta Medical Linear Accelerator 1552092

  Accelerator, linear, medical
  5 recalls0 reports
• Elekta Medical Linear Accelerator 1550358

  Accelerator, linear, medical
  4 recalls2 reports
• Elekta Medical Linear Accelerator 1552091

  Accelerator, linear, medical
  4 recalls1 report
• Elekta Medical Linear Accelerator 1550359

  Accelerator, linear, medical
  4 recalls0 reports
• Elekta Medical Linear Accelerator 1550357

  Accelerator, linear, medical
  3 recalls1 report
• Elekta Medical Linear Accelerator 1553032

  Accelerator, linear, medical
  2 recalls0 reports
• Elekta Medical Linear Accelerator 1555143

  Accelerator, linear, medical
  2 recalls0 reports

Recent Elekta Medical Linear Accelerator adverse event reports

The 10 most recent reports across all models, 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 ↗
• MalfunctionOct 2, 2025Grounding Malfunction; Grounding Malfunction

  ELEKTA HAVE IDENTIFIED A SAFETY ISSUE RELATING TO THE MODULATOR DISCHARGE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23197719 ↗
• 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 ↗
• MalfunctionSep 11, 2024Grounding Malfunction; Grounding Malfunction

  THE CUSTOMER REPORTED THAT THEY BELIEVE EXCESS DOSE IS BEING DELIVERED TO THE PATIENT BEFORE THE BEAM TERMINATES.

  Patient problems: Insufficient Information

  MAUDE report 20188519 ↗
• MalfunctionJan 10, 2024Insufficient Cooling; Electrical /Electronic Property Problem; Overheating of Device; Device Sensing Problem; Insufficient Cooling; Electrical /Electronic Property Problem; Overheating of Device; Device Sensing Problem

  THE CUSTOMER REPORTED BENDING MAGNET FAILURE.

  Patient problems: Insufficient Information

  MAUDE report 18484902 ↗
• InjuryDec 29, 2023Misassembled During Installation; Misassembled During Installation

  THE CUSTOMER REPORTED THAT THE VAULT DOES NOT HAVE ENOUGH PROTECTION FOR 10MV BEAM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 18418214 ↗
• 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 Elekta Solutions AB products

• MOSAIQ6 models · 185 reports · 7 recalls