FDR Go 566-20000-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04540217059379), received between Mar 20, 2023 and Jul 1, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unstable” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Arcing; Arcing

  WE RECEIVED THE FOLLOWING REPORT FROM FUJIFILM. ON APRIL 16TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. THE ISSUE WAS THAT THE PLUG MAY NOT BE GROUNDED, SPARKING INSIDE OF CLEAR HOUSING AND CAUSING THE PLUG TO HEAT UP. THE INJURY TO THE USER OR ANY PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED AT THIS TIME. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368624 ↗
• MalfunctionMay 16, 2025Sparking; Sparking

  ON APRIL 16TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. THE ISSUE WAS THAT THE PLUG MAY NOT BE GROUNDED, SPARKING INSIDE OF CLEAR HOUSING AND CAUSING THE PLUG TO HEAT UP. THE INJURY TO THE USER OR ANY PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED AT THIS TIME. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035997 ↗
• MalfunctionMay 9, 2024Installation-Related Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Installation-Related Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  ON APRIL 12, WE WERE NOTIFIED BY THE IMPORTER OF THE DEVICE, FUJIFILM HEALTHCARE AMERICAS, THAT IT HAD SUBMITTED AN MDR (REPORT NO: 1000513161-2024 00025) TO THE FDA WITH THE FOLLOWING INFORMATION: ON MARCH 27TH 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE PEDS ABDOMEN IS DEFAULTING TO ADULT ABDOMEN TECHNIQUES. THERE IS NO ADDITIONAL INFORMATION PROVIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276059 ↗
• MalfunctionApr 11, 2024Installation-Related Problem; Installation-Related Problem

  ON (B)(6) 2024 FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE PEDS ABDOMEN IS DEFAULTING TO ADULT ABDOMEN TECHNIQUES. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091213 ↗
• MalfunctionMar 28, 2023Unstable; Unstable

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE SCREWS ON THE COLLIMATOR RING ARE BECOMING LOOSE OVER TIME CAUSING THE COLLIMATOR TO BECOME UNSTABLE. THERE IS NO PATIENT INVOLVEMENT OR REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629272 ↗
• MalfunctionMar 28, 2023Unstable; Unstable

  ON MARCH 13, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE SCREWS ON THE COLLIMATOR RING ARE BECOMING LOOSE OVER TIME CAUSING THE COLLIMATOR TO BECOME UNSTABLE. THERE IS NO PATIENT INVOLVEMENT OR REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629270 ↗
• MalfunctionMar 28, 2023Unstable; Unstable

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE SCREWS ON THE COLLIMATOR RING ARE BECOMING LOOSE OVER TIME CAUSING THE COLLIMATOR TO BECOME UNSTABLE. THERE IS NO PATIENT INVOLVEMENT OR REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629261 ↗
• MalfunctionMar 20, 2023Radiation Overexposure; Radiation Overexposure

  ON FEBRUARY 21, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT A 6-MONTH-OLD INFANT RECEIVED ONE ADDITIONAL IMAGING SCAN AT A HIGHER EXPOSURE RATE. THE TECHNICIAN PERFORMED THE INITIAL SCAN AT A RATE OF 80KV AND 14 MAS WHICH WAS THE RATE USED ON AN ADULT PATIENT PRIOR. THE TECHNICIAN NOTICED THAT THE KV AND MAS WERE INCORRECTLY SET FOR AN INFANT SCAN AND A SECOND EXPOSURE WAS RETAKEN AT THE CORRECTED RATE OF 63KV AND 1.6 MAS. IT IS UNCLEAR IF THE ADDITIONAL EXPOSURE COULD LEAD TO A SAFETY RISK. THEREFORE, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THERE IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573944 ↗