OEC ELITERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682121729), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 death.

4 FDA recall records name this device's identifier, 4 still open.

2 other recalls cover devices cleared under the same FDA submission (K170752, K171565, K172550, K192819); 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. Jan 31, 2025Open, Classified

   For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

   Z-1239-2025 · Root cause: Software design · FDA record ↗

2. Nov 21, 2024Open, Classified

   Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

   Z-0703-2025 · Root cause: Process control · FDA record ↗

3. Nov 21, 2024Open, Classified

   Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.

   Z-0704-2025 · Root cause: Process control · FDA record ↗

4. May 15, 2023Open, Classified

   Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

   Z-2278-2023 · Root cause: Process control · FDA record ↗

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.

• DeathMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, AN INTERNAL EMAIL ORIGINATING FROM A CUSTOMER SITE WAS SENT TO A GE HEALTHCARE (GEHC) SALES REPRESENTATIVE INDICATING THAT A PATIENT EXPIRATION HAD OCCURRED AND THAT THE EVENT WAS POTENTIALLY ASSOCIATED WITH A GE HEALTHCARE C ARM. THE CONTENT OF THE CUSTOMER¿S EMAIL DESCRIBED THE FOLLOWING SEQUENCE OF EVENTS: 1. THE PATIENT PRESENTED FOR A ROUTINE UROLOGIC PROCEDURE REQUIRING INTRAOPERATIVE FLUOROSCOPY. 2. THE GEHC C ARM EQUIPMENT WAS MANEUVERED TO OBTAIN THE DESIRED VIEW. 3. THE CLINICAL TEAM DID NOT RECOGNIZE AN IMAGE INVERSION AND SUBSEQUENTLY REQUESTED ADMINISTRATION OF CONTRAST DYE. 4. AN INCORRECT DOSE OF CONTRAST DYE WAS ADMINISTERED, WHICH THE CUSTOMER REPORTED AS LEADING TO ¿CATASTROPHIC OUTCOMES,¿ INCLUDING A REPORTED PATIENT EXPIRATION. NO ADDITIONAL INFORMATION REGARDING THE DATE OF THE PROCEDURE, SPECIFIC DEVICE SETTINGS, IMAGES, WORKFLOW STEPS, OR ANY DIRECT OBSERVATIONS FROM GEHC PERSONNEL HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24687627 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170752, K171565, K172550, K192819. One submission often covers many models, so check the product and lot details in each record.

• Z-1819-2025 · Mar 21, 2025 · Open, Classified
  OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during d
• Z-2161-2021 · Jun 10, 2021 · Terminated
  OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during di