GE OEC Medical Systems, Inc: Device Recall

Recall Details

Recall Number

Z-0706-2025

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

25 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 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room 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 →