Recall Z-1819-2025— GE Medical Systems, LLC

Name: FDA recall Z-1819-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-03-21. It names 4 FDA 510(k) clearances: K192819, K172550, K171565 and 1 more. Product: 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 diagnostic, interventional, and surgical procedures.. Reason: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-21
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 on FDA's record

K192819 — OEC EliteGe Oec Medical Systems, Inc.·cleared 2019-11-08
K172550 — OEC EliteGe Oec Medical Systems, Inc.·cleared 2017-11-16
K171565 — OEC EliteGe Oec Medical Systems, Inc.·cleared 2017-08-10
K170752 — OEC EliteOec Medical Systems, Inc.·cleared 2017-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 diagnostic, interventional, and surgical procedures.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.