Precision 500DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682119238), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Defective Device

  OUTPATIENT ARRIVED AT THE X-RAY DEPARTMENT TO HAVE AN ESOPHAGRAM AND VIDEO SWALLOW PERFORMED. THE PATIENT WAS BROUGHT INTO THE ROOM IN THE XRAY DEPARTMENT. THE EXAM WAS BEGUN WITH THE ESOPHAGRAM USING LIVE FLUORO. THE RADIOLOGIST THEN REQUESTED OVERHEAD IMAGING. THE PATIENT WAS EXPOSED TO RADIATION WITHOUT PRODUCING AN IMAGE TWICE AS THE EQUIPMENT MALFUNCTIONED. BIOMED WAS THEN CALLED. THE BIOMED ENGINEER RESTARTED THE ROOM, THE ROOM CAME BACK UP STILL NOT WORKING ABOUT 10 MINUTES LATER. THE ROOM THEN NEEDED TO BE "HARD WIRED" SHUT DOWN BY OPENING UP THE BIG BOX IN THE CORNER OF THE ROOM. ALL THIS TIME OUR PATIENT WAS LAYING ON THE TABLE. THE PATIENT WAS ELDERLY AND VERY UNCOMFORTABLE, ALTHOUGH WE PROVIDED AS MUCH COMFORT AS POSSIBLE DURING THIS TIME. ULTIMATELY, THE PATIENT HAD TO BE MOVED TO A DIFFERENT ROOM TO FINISH THE EXAMS THAT WERE ORDERED. BIOMED FOLLOW UP: GE SYSTEM WILL NOT X-RAY. A SIMPLE RESTART DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS POWERED DOWN, CABINET BREAKER DISCONNECT AND SYSTEM LEFT OFF FOR ONE MINUTE. REVERSED THE PROCESS AND POWERED ON. AFTER BOOTING, THE SYSTEM WAS PROPERLY SHUT DOWN AND RESTARTED. THE SYSTEM OPERATED AS INTENDED.

  Patient problems: Discomfort; Unintended Radiation Exposure

  MAUDE report 16712555 ↗