OEC Elite

• • Ongoing Z-1819-2025 FDA Class II ·initiated 21 Mar 2025

  OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

• • Ongoing Z-0704-2025 FDA Class II ·initiated 21 Nov 2024

  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.

• • Ongoing Z-2278-2023 FDA Class II ·initiated 15 May 2023 ·on shared 510(k) K192819

  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.

• • Terminated Z-2161-2021 FDA Class II ·initiated 10 Jun 2021 ·on shared 510(k) K192819

  There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K192819 ↗

FDA Product Code

OXO

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• OEC Elite Open recall

  Class II

  FDA 510(k) K171565 Active Cleared 10 Aug 2017

• Oec 3D Open recall

  Class II

  FDA 510(k) K203346 Active Cleared 5 Mar 2021

• Oec Olympus Mobile Fluoroscopy System with Integrated Navigation

  Class II

  FDA 510(k) K041931 Active Cleared 26 Aug 2004

• GE Oec Everview 7500

  Class II

  FDA 510(k) K051490 Active Cleared 7 Jul 2005

• Oec Fluorotrak 9800 Plus

  Class II

  FDA 510(k) K022069 Active Cleared 17 Sep 2002

• Oec 9800 Plus Digital Mobile Imaging System Open recall

  Class II

  FDA 510(k) K021049 Active Cleared 17 Apr 2002

See all devices from GE Oec Medical Systems, Inc →