GE OEC Medical Systems, Inc: Medical Device Recall in 2023 - (Recall #: Z-2276-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

OEC 9800 Systems with 9-inch Image Intensifier

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2276-2023

Event ID: 92504

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.

Status: Ongoing

Product Quantity: 58

Code Information:

UDI-DI: 00840682114349. Serial Numbers: 89-0317, 89-0554, 8S-1293, 8S-0509, 8S-0108, 8S-1029, 8S-2836, 89-3028, 8S-1574, 89-0609-RC, 89-1308, 8S-0394, 89-0979, 8SXXXX03626, 8SXXXX03683, 8SXXXX03681, 8S-1894, 8S-0175, 8S-2988, 89-2459, 89-2101, 89-3245, 89-1623, 89-0296, 8S-0200, 8S-0748, 89-1590, 89-1713, 8S-0124, 89-0282, 8S-2580, 89-3132, 8S-3039, 89-3451, 89-0223, 89-1155, 8SXXXX03680, 8S-3278, 8S-2426, 89-2913, 8S-1167, 89-1278, 89-1854, 8S-0233-C, 8S-1926, 8SXXXX03682, 89-2167, 8S-1109, 8SXXXX03679, 8S-0410, 89-1579-N, 89-1920, 89-3102, 8S-2046-C, 89-2340, 89-0461, 89-3809, 89-3810

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.

Voluntary or Mandated:

Voluntary: Firm initiated