Elekta Unity 1536549Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060191071321), received between Feb 5, 2019 and Apr 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (3 reports).

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K182076); 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. May 21, 2020Terminated

   In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.

   Z-2297-2020 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Computer Software Problem; Failure to Read Input Signal; Computer Software Problem; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT AN INCOMPLETE PLAN INFORMATION WAS IMPORTED IN MOSAIQ FOR (ONLINE) MR-LINAC TREATMENT.

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

  MAUDE report 13977005 ↗
• MalfunctionMar 26, 2020Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT WHIST PERFORMING AN ADAPT TO SHAPE POSITION (ATS) IT WAS IMPOSSIBLE TO GET A CALCULATION (CALCULATION FAILURE). THE CUSTOMER WAS ABLE TO CALCULATE ONCE THEY USED ADAPT TO POSITION (ATP).  THE CUSTOMER ALSO REPORTED THAT THE MOTION MONITORING STRUCTURE WAS DISPLACED. NO PATIENTS WERE MISTREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9882880 ↗
• MalfunctionMay 24, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT THE MR TO MV VALUE CANNOT BE CHECKED.

  Patient problems: No Patient Involvement

  MAUDE report 8640069 ↗
• MalfunctionApr 23, 2019Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT THE ON-GANTRY EPID (ELECTRONIC PORTAL IMAGING DEVICE) DRIFTED POSITION OVER SEVERAL MONTHS DUE TO A LOOSE NUT.

  Patient problems: No Patient Involvement

  MAUDE report 8540008 ↗
• MalfunctionApr 18, 2019Computer Software Problem; Computer Software Problem

  THIS WAS DETECTED AT THE (B)(6) SITE, UNITY M/C 600014. THE MACHINE IS NOT CLINICAL. DURING THE UNITY PHYSICS TRAINING, IT WAS DISCOVERED THAT THE MR-MV OFFSET IN THE EQUATOR DATABASE IS SET TO 0,0,0. THE ACTUAL OFFSET, AS MEASURED USING THE STANDARD QA PROCEDURE, IS -0.05MM, 3.05MM AND -0.21MM (X, Y, Z RESPECTIVELY). THIS WAS DETECTED BY OBSERVATION OF THE ISOCENTRE POSITION IN AN ADAPT TO SHAPE PLAN AND CONFIRMED BY DIRECT INSPECTION OF THE TREATMENTDEVICESMACHINEMRCORRECTION FIELD IN THE EQUATOR DATABASE. SINCE THE VALUE IN THE DATABASE WAS 0,0,0 AND NOT BLANK, IT WAS POSSIBLE TO FULLY COMPLETE THE TREATMENT WORKFLOW WITHOUT ANY ERRORS AND, AS A CONSEQUENCE, ALL ADAPTED PLANS WOULD BE BASED ON AN INCORRECT ISOCENTRE POSITION (IN THIS CASE THIS WOULD RESULT IN A 3 MM ERROR IN THE Y DIRECTION). AFTER INVESTIGATION WE CAN CONFIRM THAT THE INSTALLATION PROCESS WAS NOT FOLLOWED AS DESCRIBED IN "INSTALLATION PHASE 2 AND STWD2 MANUAL (1530419). THE EQUATOR (EQ) DATABASE IS INSTALLED BEFORE STW2 (INSTALLATION PROCESS). THE WORKFLOW THAT HAS TAKEN PLACE IN UPPSALA WHERE STW2 WAS PERFORMED WHILST THE EQ DATABASE WAS NOT AVAILABLE. THE CALCULATED MR TO MV OFFSET VALUES WERE NOT EXPORTED TO

  Patient problems: No Patient Involvement

  MAUDE report 8526415 ↗
• MalfunctionFeb 5, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  NO ADVERSE EVENT HAS OCCURRED. WARNINGS REGARDING PREGNANCY AND THE MRI IMAGING USING THE MR LINAC ARE NOT CONTAINED WITHIN THE INSTRUCTIONS FOR USE. UNDER NORMAL MR OPERATING CONDITIONS (RADIOLOGY USE), PREGNANCY REQUIRES THE MR USER TO MAKE CHANGES TO AVAILABLE SEQUENCES IN ORDER TO LIMIT THE SPECIFIC ABSORPTION RATE (SAR) AND RADIO FREQUENCY (RF) EFFECTS TO THE FOETUS. HOWEVER, FOR UNITY ACCESS TO AND ADJUSTMENT OF THESE PARAMETERS IS NOT AVAILABLE. PREGNANT WOMEN ARE THEREFORE CONTRAINDICATED FOR IMAGING USING THE MR LINAC. THE INSTRUCTIONS FOR USE DO NOT CONTAIN A WARNING REGARDING CONTRAINDICATION FOR IMAGING IN PREGNANCY. HOWEVER, THE SYSTEM DOES HAVE A RCM IMPLEMENTED IN THE FORM OF A MR DAILY ASSESSMENT CHECKLIST THAT CONTAINS A QUESTION ON WHETHER THE PATIENT IS PREGNANT OR NOT. IF THIS ANSWER TO THIS QUESTION IF "YES" - IMAGING WOULD NOT START.

  Patient problems: No Patient Involvement

  MAUDE report 8304539 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182076. One submission often covers many models, so check the product and lot details in each record.

• Z-1980-2019 · Jun 24, 2019 · Terminated
  Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatmen
• Z-1297-2019 · Apr 3, 2019 · Terminated
  Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant
• Z-1109-2019 · Mar 12, 2019 · Terminated
  Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic rad
• Z-0706-2019 · Jan 4, 2019 · Completed
  Elekta Unity