Lower riskMedical device recall · FDA · Published June 10, 2021
GE OEC Medical X-Ray System Recall: Battery Depletion Risk
GE OEC recalls mobile fluoroscopy X-ray systems due to potential coin cell battery depletion causing system inoperability. Affected units may require replacement.
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.
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Contact the company
📍Recalling firmGE OEC Medical Systems, Inc384 N Wright Brothers Dr · Salt Lake City, UT 84116-2862
✎ GovInfoNow plain-language explainer
GE OEC is recalling mobile fluoroscopy X:ray systems because the coin cell battery that monitors X-ray tube temperature may deplete early, causing the system to stop working. This could lead to interrupted medical procedures if the system becomes inoperable during critical treatments. Read more at govinfonow.com/recall/62354-ge-oec-medical-x-ray-system-recall-battery-depletion-risk.
“GE OEC Medical X-Ray System Recall: Battery Depletion Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62354-ge-oec-medical-x-ray-system-recall-battery-depletion-risk. Based on FDA recall #Z-2160-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2160-2021%22&limit=1).
GE OEC Medical Systems, Inc. recalled its OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile due to a potential early depletion of the coin cell battery that monitors X-ray tube temperature, which may cause the system to become inoperable, according to the FDA on June 10, 2021.
How to tell if you have it
GE OEC
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile
All OEC 3D Systems
The hazard
The recall addresses the potential that the coin cell battery used to monitor X-ray tube temperature may deplete early, causing the system to become inoperable.
Context
GovInfoNow's records show GE OEC Medical Systems, Inc. has two other recalls on record since May 15, 2023. On November 21, 2024, the company recalled the GE OEC OEC 9800 X-Ray System due to an oil leak risk. Other recent recalls of similar products include the GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026) and the GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (April 20, 2026).
How to tell if you have this one
This recall applies to GE OEC's mobile fluoroscopy X-ray systems used for adult and pediatric imaging during procedures. The product is designed for diagnostic, interventional, and surgical use.
Brand
GE OEC
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-2160-2021
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures; All OEC 3D Systems
3 units
Z-2161-2021
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.; All OEC Elite systems manufactured on or after January 2019
3570 units
Based on the official FDA remedy
What to do — step by step
Check System Status
Verify if the system has a coin cell battery that monitors X-ray tube temperature.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 36 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Utah, Vermont, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2160-2021 (June 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2160-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.