NA GC80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08806086403467), received between Jun 22, 2017 and May 4, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143029); 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.

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.

• InjuryMay 4, 2018Adverse Event Without Identified Device or Use Problem

  DURING A GC80 SCANNING OF THE PATIENT FOREARM, THE TECHNICIAN WAS USING THE REMOTE TO LOWER THE TABLE ONTO THE PATIENT'S LEGS. THE PATIENT GOT SCARED AND PUSHED OUT FROM UNDER THE GC80'S TABLE SCRAPING HIS LEGS.

  Patient problems: Injury

  MAUDE report 7486576 ↗
• InjuryJun 22, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN L-SPINE FERGUSON AT THE WALL STAND, A SEATED EXAM, THE TUBE HEAD DID NOT STOP AND HIT THE PATIENT'S KNEE.

  Patient problems: Injury

  MAUDE report 6661103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143029. One submission often covers many models, so check the product and lot details in each record.

• Z-0726-2018 · Jun 22, 2017 · Terminated
  The GC80 Digital X-ray Imaging System