OEC 3D REF Image-Intensified Fluoroscopic X-Ray System — Class II medical device recall Z-0703-2025

Ongoing recall by GE OEC Medical Systems, Inc, reported 2024-12-25, distributed in AK, AZ, CA, CO, CT, DC, FL, GA…. Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and l

Recall number	`Z-0703-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	GE OEC Medical Systems, Inc, Salt Lake City, UT, United States
Recall initiated	2024-11-21
Classified	2024-12-18
Reported by FDA	2024-12-25
Distributed	AK, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY
Countries outside the US	AU, BR, CA, CH, CL, CR, GB, IN, IT, PH, PL, PT, SE
Quantity	84 systems
Reason classes	packaging
UPC / GTIN / UDI-DI	`00195278096944`, `00840682121729`

Product

OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0703-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.