Geodesic EEG System GES 400 SeriesRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00863003000305), received between Jun 6, 2018 and Oct 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2019Break; Solder Joint Fracture; Material Integrity Problem; Break; Solder Joint Fracture; Material Integrity Problem

  THE GES400 SYSTEM WAS BEING TRANSPORTED VIA THE GES400 CART ALONG THE CORRIDOR WHEN THE CLINICIAN WAS MOVING TO THE CLINIC'S MONITORING UNIT. DURING THIS TRANSPORT, THE CAMERA POLE DETACHED FROM THE CART AND FELL TO THE GROUND IMMEDIATELY. THERE WAS NO SHRAPNEL AS THE BREAK WAS CLEAN FROM THE WELD. THE GES400 SYSTEM WAS NOT IN USE AT THE TIME OF THE CAMERA POLE MECHANICAL FAILURE. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9195123 ↗
• MalfunctionJun 6, 2018Component Falling; Material Separation; Detachment of Device or Device Component; Material Integrity Problem; Component Falling; Material Separation; Detachment of Device or Device Component; Material Integrity Problem

  THE GES 400 SYSTEM WAS BEING USED IN AN EMU ROOM TO RECORD A PATIENT'S EEG. THE GES 400 CART WAS POSITIONED NEXT TO THE PATIENT 'S BED WITH THE CAMERA PARAPET POSITIONED ABOVE THE PATIENT. THERE WERE TWO EMU STAFF NEAR THE CART, WITH THE LEAD TECHNICIAN TRAINING A NEW TECHNICIAN. THE TECHNICIANS WERE ADJUSTING THE CAMERA POLE HIGHER (PRESSED BUTTON TO RAISE THE POLE) WHEN THEY NOTICED THAT THE CAMERA POLE BECAME DETACHED FROM THE BASE AS IT WAS BEING RAISED. THE LEAD TECHNICIAN ASKED THE NEW TECHNICIAN TO HOLD THE POLE TO SUPPORT THE CAMERA WHILE SHE WENT TO GET THE EEG DEPARTMENT MANAGER. WHEN THE MANAGER CAME TO THE ROOM, THEY ASSESSED THE SITUATION AND FURTHER MOVEMENT CAUSED THE CAMERA POLE TO MECHANICALLY DETACH FROM THE CART AS IT WAS BEING HELD. THE CAMERA POLE REMAINED CAPTIVE TO THE CART BY WAY OF THE CAMERA SIGNAL CABLE INSIDE OF THE POLE. THE SEPARATION WAS CONTROLLED AND NO DEBRIS WAS RELEASED; THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ALLEGATION OF PATIENT OR USER INJURY. THE EEG CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574942 ↗