NA GM85Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08806088582412), received between Jan 11, 2021 and Nov 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K162278, K171119, K180543, K181626, K182183, K220175, K222353); 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.

Recalls naming this device

1. Oct 7, 2025Open, Classified

   The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.

   Z-0480-2026 · Root cause: Device Design · FDA record ↗

2. Dec 28, 2023Open, Classified

   Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.

   Z-1056-2024 · Root cause: Process design · FDA record ↗

3. Mar 8, 2023Open, Classified

   Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm

   Z-1414-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM SHUTS DOWN DURING EXAMS, WHICH CAUSED A DELAY IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23445316 ↗
• MalfunctionApr 8, 2021Labelling, Instructions for Use or Training Problem; Human-Device Interface Problem; Unintended Movement; Labelling, Instructions for Use or Training Problem; Human-Device Interface Problem; Unintended Movement

  WHILE DRIVING THE DEVICE, THE SYSTEM ARM MOVED UNINTENTIONALLY, CAUSING THE USER'S FINGER TO GET PINCHED/CRUSHED BY THE DEVICE.

  Patient problems: Crushing Injury

  MAUDE report 11639012 ↗
• MalfunctionFeb 5, 2021Material Deformation; Material Deformation

  TECHNICIAN BURNED HIS FINGER WHEN THEY TOUCHED THE POWER CORD. IT WAS NOTED THAT THE TECH'S FINGER WAS A LITTLE RED BUT THEY DID NOT NEED MEDICAL ATTENTION.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 11283801 ↗
• MalfunctionJan 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER WAS USING THE SYSTEM IN THE EMERGENCY DEPARTMENT. WHILE THE DEVICE WAS NOT BEING DRIVEN, BUT ON BATTERY POWER, SMOKE APPEARED ON THE RIGHT SIDE. THE SITE CALLED THE FIRE DEPARTMENT AND THE SYSTEM WAS MOVED TO A SAFE AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152962 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162278, K171119, K180543, K181626, K182183, K220175, K222353. One submission often covers many models, so check the product and lot details in each record.

• Z-1691-2019 · May 6, 2019 · Terminated
  Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a