Recall Z-1820-2025— GE Medical Systems, LLC

Name: FDA recall Z-1820-2025
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 2 FDA 510(k) clearances: K233669, K203346. Product: OEC 3D. 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

2 on FDA's record

K233669 — OEC 3DGe Oec Medical Systems, Inc.·cleared 2024-03-28
K203346 — OEC 3DGe Oec Medical Systems, Inc.·cleared 2021-03-05

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 3D

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.