Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System Recalled by GE OEC Medical Systems, Inc Due to Due to manufacturing issue of insufficient sealing of...

Date: November 21, 2024
Company: GE OEC Medical Systems, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE OEC Medical Systems, Inc directly.

Affected Products

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. 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.

Quantity: 100 systems

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 44 states: AK, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC

Affected (44 states)Not affected

About GE OEC Medical Systems, Inc

GE OEC Medical Systems, Inc has 48 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report