Home / Recalls / GE OEC Medical Systems, Inc / Z-2161-2021

Z-2161-2021 Class II Terminated

Recalled by GE OEC Medical Systems, Inc — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
June 10, 2021
Termination Date
May 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3570 units

Product Description

OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

Reason for Recall

There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, PA, WA, OH, LA, MS, AL, FL, MO, OK, AZ, NJ, CO, MI, NV, MN, KS, TN, NC, IL, MD, SC,GA, UT, WI, MT, AR, WV, ID,CT, IA, WY, VT, KY, DC, SD,ME, Virgin Islands and the countries of Colombia, Egypt, Peru, Chile, Spain, France, Germany, Hong Kong, Canada, Japan, Brazil, Turkey, United Arab Emirates, Singapore, Australia, Thailand, United Kingdom, Italy, Korea, Russia, CHINA, Romania, Nigeria, Czechia, Argentina, Taiwan, Bangladeh, Malaysia, Bosnia and Herzegovina, Poland, Belgium, Indonesia, Dominican Republic, Switzerland, Hungary, New Zealand, Vietnam, Mexico, India, Norway, Philippines, Ecuador, Lithuania, HONDURAS, Uruguay, Sweden, Croatia, Jamaica, Kuwait, Ethiopia, Saudi Arabia, Finland, Bahamas, Trinidad and Tobago, Pakistan, Slovakia, Costa Rica, Israel, Panama, Greece, South Africa and DENMARK.

Code Information

All OEC Elite systems manufactured on or after January 2019

Other recalls by GE OEC Medical Systems, Inc

  • Z-0704-2025 Class II — OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC E (November 21, 2024)
  • Z-0703-2025 Class II — OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D i (November 21, 2024)
  • Z-0706-2025 Class II — OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series (November 21, 2024)
  • Z-0705-2025 Class II — OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 99 (November 21, 2024)
  • Z-2276-2023 Class II — OEC 9800 Systems with 9-inch Image Intensifier (May 15, 2023)
  • Z-2279-2023 Class II — Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, (May 15, 2023)
  • Z-2278-2023 Class II — OEC Elite Systems with 9-inch Image Intensifier (May 15, 2023)
  • Z-2275-2023 Class II — OEC Flexiview 8800 Systems with 9-inch Image Intensifier (May 15, 2023)
  • Z-2277-2023 Class II — OEC 9900 Systems with 9-inch Image Intensifier (May 15, 2023)
  • Z-2160-2021 Class II — OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Us (June 10, 2021)