GE OEC Medical Systems, Inc: Device Recall

Recall Details

Recall Number

Z-0703-2025

Classification

Class II

Product Type

Device

Recalling Firm

GE OEC Medical Systems, Inc

Status

Ongoing

Date Initiated

11/21/2024

Location

Salt Lake City, UT, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

84 systems

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.

Product Description

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.

Distribution Pattern

U.S.: AK, AZ, CA, CO, CT, DC, FL, GA, Guam, 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, and WY. O.U.S.: Australia, Brazil, Canada, Chile, Costa Rica, India, Italy, Philippines, Poland, Portugal, Sweden, Switzerland, and United Kingdom

Other Recalls by GE OEC Medical Systems, Inc

• Class II: Risk 11/21/2024
  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.
• Class II: Risk 11/21/2024
  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.
• Class II: Risk 11/21/2024
  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.

View all recalls by GE OEC Medical Systems, Inc →