GE OEC Medical Systems, Inc: Medical Device Recall in 2021 - (Recall #: Z-2161-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 10, 2021

Date Posted: August 4, 2021

Recall Number: Z-2161-2021

Event ID: 88202

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.

Status: Terminated

Product Quantity: 3570 units

Code Information:

All OEC Elite systems manufactured on or after January 2019

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.

Voluntary or Mandated:

Voluntary: Firm initiated