NA 1525717Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060191071017), received between Aug 31, 2023 and Oct 26, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Low impedance” (1 report).

1 FDA recall record name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K051932); 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.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A RADIATION EXPOSURE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 18011715 ↗
• MalfunctionOct 18, 2023Low impedance; Low impedance

  ON SUNDAY SEPTEMBER 17TH THE IN-HOUSE HOSPITAL TEAM HAD BEEN RUNNING EXPERIMENTAL CLINICAL BEAMS WITH THE VERSA HD LINAC (OUTSIDE OF CLINICAL HOURS & NOT TREATING PATIENTS). HAVING EXPERIENCED REPEATED INHIBITS OF LOW DOSE RATE DURING THE DAY, AT 6:40 P.M THE DOSE RATE OF THE BEAM DROPPED FROM 570 TO 430. THE HOSPITAL TEAM STARTED INVESTIGATING THE LOW DOSE FAULT. ELEKTA RECEIVED A CALL FROM THE HOSPITAL ENGINEER REQUESTING ASSISTANCE IN THE REPAIR. THE VERSA HD LINAC WAS RUNNING IN SERVICE MODE WITH INTERLOCKS OVERRIDDEN. THE HOSPITAL ENGINEERS WHEN JOINED BY ELEKTA SERVICE ENGINEER AT 8:10 PM, THEY REPORTED NO OBVIOUS ABNORMALITIES WHEN VIEWING THE RELEVANT PARAMETERS. THE MACHINE WAS SHUT DOWN AND RESTARTED AT ABOUT 8:20 P.M. (THE VERSA HD WAS OPERATING IN CTRL T INTERLOCK GROUP & SERVICE MODE WITH ALL INTERLOCKS OVERRIDDEN). THE MACHINE STILL REPORTED THE SAME FAULT, LOW DOSE RATE. THE ELEKTA ENGINEER FOLLOWED BY THE HOSPITAL ENGINEER WENT TO THE SPARE PARTS ROOM ON THE 2ND FLOOR TO OBTAIN MEASUREMENT EQUIPMENT IN PREPARATION FOR PERFORMING MEASUREMENT TESTS ON THE VERSA HD, ABOUT 2-3 MINUTES LATER BACK TO THE OPERATION ROOM, HT PSU OT AND OTHER FAULTS, WERE DISPLAYED, RESETTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955710 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A RADIATION EXPOSURE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 17660961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051932. One submission often covers many models, so check the product and lot details in each record.

• Z-2840-2018 · Dec 1, 2017 · Terminated
  ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
• Z-2721-2016 · Jul 8, 2016 · Terminated
  Medical Linear Accelerator
• Z-1088-2015 · Jan 7, 2015 · Terminated
  Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-1061-2014 · Nov 25, 2013 · Terminated
  Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-1065-2014 · May 28, 2013 · Terminated
  All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
• Z-0931-2013 · Dec 19, 2012 · Terminated
  Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
• Z-2405-2012 · Aug 6, 2012 · Terminated
  Precise Digital Accelerator Delivery of radiation to defined target volumes
• Z-3079-2011 · May 6, 2011 · Terminated
  Elekta Synergy The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-0305-2012 · Mar 9, 2011 · Terminated
  Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-1252-2011 · Jan 5, 2011 · Terminated
  Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-1723-2011 · Oct 25, 2010 · Terminated
  Elekta Synergy XVI R4.5 Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-0350-2011 · Sep 1, 2010 · Terminated
  Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
• Z-1405-2010 · Dec 12, 2008 · Terminated
  Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant
• Z-1411-2010 · Sep 19, 2007 · Terminated
  Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.