FDR Go 503-79888-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04540217053438), received between Jul 17, 2017 and Apr 10, 2020 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2020Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  WHEN THE USER WAS REVERSING THE FDR GO AFTER THE USER WAS FINISHED TAKING AN X-RAY OF PATIENT IN THE BED AND WAS BACKING THE GO AWAY FROM THE BED, THE FDR GO MADE A SUDDEN MOVEMENT TURN AND BACK LEFT WHEEL RAN OVER THE USER'S RIGHT FOOT. SERVICE ENGINEER WAS ONSITE, HE SAYS USER WAS USING ONLY ONE HAND TO DRIVE THE FDR GO, SO THAT'S WHY THE FDR GO TURNED ONE WAY. USER SUFFERED MODERATE BRUISING OF HER FOOT, HOWEVER THERE WERE NO BROKEN BONES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9947492 ↗
• DeathJul 17, 2017Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED ON 08/31/2017 FOR THE INITIAL MDR, 2443168-2017-00002, SUBMITTED ON 7/17/2017 IN AN ABUNDANCE OF CAUTION. THE INFORMATION IN THIS SUPPLEMENTAL REPORT SUPERSEDES AND CORRECTS ANY INFORMATION PREVIOUSLY REPORTED TO THE FDA BY FMSU FOR THE MDR, 2443168-2017-00002. FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) HAS BEEN UNABLE TO DISCOVER ANY PATIENT INJURY OR DEATH ASSOCIATED WITH THE REPORTED INCIDENT. FMSU HAS CONCLUDED THAT THE FDR GO WAS NOT INVOLVED IN THIS REPORTED INCIDENT. SAT (B)(6) 2017: FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) TECHNICAL ASSISTANCE CENTER (TAC) RECEIVED A SERVICE REQUEST CALL FROM THE HOSPITAL REGARDING A FAILURE TO TRANSFER IMAGES BETWEEN FDR GO AND THE HOSPITALS PACS SYSTEM DUE TO ISSUES WITH WI-FI CONNECTIVITY BETWEEN THE FDR GO AND THE HOSPITAL PACS SYSTEM. DURING THE CALL, FMSU RECEIVED A COMPLAINT OF A PATIENT DEATH OR INJURY WHERE THE COMPLAINANT CLAIMED THAT THE LOSS OF CONNECTIVITY BETWEEN FDR GO AND THE HOSPITAL PACS SYSTEM WAS A CAUSAL FACTOR. NO FURTHER INFORMATION ON THE REPORTED INCIDENT WAS SHARED BY THE COMPLAINANT WITH THE FMSU TAC REPRESENTATIVE DURING THE CALL. MON JUNE 19, 2017: FMSU ATTEMPTED

  Patient problems: Death

  MAUDE report 6719677 ↗