CLASS II Device recall · Reported 4 Aug 2021 · FDA Enforcement Report

OEC Elite mobile C-arm recalled by GE OEC Medical Systems

GE OEC Medical Systems is recalling OEC Elite mobile C-arm, distributed nationwide in the US. The recall was initiated on 10 Jun 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll OEC Elite systems manufactured on or after January 2019

Quantity recalled3570 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2161-2021
FDA event ID: 88202
Recalling firm: GE OEC Medical Systems, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2021
FDA classified: 29 Jul 2021
Reported: 4 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Surgical Instruments

Timeline

10 Jun 2021	Recall initiated by company
29 Jul 2021	Classified by FDA	+49 days
4 Aug 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Kansas Kentucky Louisiana Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All OEC Elite systems manufactured on or after January 2019

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88202

This product is part of a recall event; the main page for the event is OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile recalled.

Reported	Class	Recall	Company	Reason	Where
4 Aug 2021	CLASS II	OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile recalled	GE OEC Medical Systems	Temperature Abuse	Nationwide

More recalls from GE OEC Medical Systems

All 47

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Device	CLASS II	OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System recalled	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC Elite recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
25 Dec 2024Device	CLASS II	OEC 3D recalled by GE OEC Medical Systems	GE OEC Medical Systems	Packaging Defects	44 states
9 Aug 2023Device	CLASS II	OEC Elite Systems with Image Intensifier recalled	GE OEC Medical Systems	Other	Nationwide

Other Surgical Instruments recalls

All 3,883

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7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled	ASP Global	Device Malfunction	Nationwide