Elekta Medical Linear Accelerator 1550358Recalls & reported problems
Elekta Solutions AB · Elekta Infinity™ · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060191071512), received between Dec 29, 2023 and Sep 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Grounding Malfunction” (1 report).
4 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-0446-2024 · 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 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
- Grounding Malfunction1
- Misassembled During Installation1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
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 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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