Home / Recalls / GE OEC Medical Systems, Inc / Z-2279-2023

Z-2279-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 9, 2023
Initiation Date
May 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16

Product Description

Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 INCH, TOSHIBA; P/N 5761613 SERVICE PART, IMAGE INTENSIFIER, 9 INCH - used with OEC Flexiview 8800, OEC 9800, and OEC 9900 Systems

Reason for Recall

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.

Code Information

P/N/Sales Order Number: 5451208/80165102, 80171955, 80173514, 80162453, 80183950, 80151733, 80163547, 80171532, 80156410, 80176650, 10530514, 105449333, 80167595; 5485304/10557644, 118687327; 5761613/10283014, 10152211, 105108003, 105114645. OEC 9800, UDI-DI: 00840682114349; OEC 9900 Systems, UDI-DI: 00840682114301

Other recalls by GE OEC Medical Systems, Inc

  • Z-0706-2025 Class II — OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series (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-0705-2025 Class II — OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 99 (November 21, 2024)
  • Z-0704-2025 Class II — OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC E (November 21, 2024)
  • Z-2276-2023 Class II — OEC 9800 Systems with 9-inch Image Intensifier (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-2161-2021 Class II — OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and dig (June 10, 2021)
  • Z-2160-2021 Class II — OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Us (June 10, 2021)