GE OEC Medical Systems, Inc: 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

Recall number

Z-2160-2021

Recalling firm

GE OEC Medical Systems, Inc

Product

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

Status

Terminated

Initiated

2021-06-10

Posted

not on file

Terminated

2024-05-09

Reason

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.

Root cause

Under Investigation by firm

Action

On June 11, 2021, GE Healthcare issued an "Urgent Medical Device Correction via certified mail to all affected consignees. In addition to informing consignees about the recalled product, the firm asked customers to take the following actions: 1. You may continue to use your system. 2. Please disseminate this information to applicable users within your facility. 3. When the system is not in use, it is recommended to connect the system to power with the workstation plugged in and the interconnect cable attached to the mainframe, to reduce potential battery depletion. It is not necessary to turn the workstation power on. 4. Prior to each use, please follow the Start Up Checklist in the System Set Up section (Section 2) of the OEC Elite or OEC 3D Operator Manuals and verify that no error message is displayed on the touch panels or the monitor. a. If the system displays the following error message, as described in the Troubleshooting and messages section (Section 14) of the OEC Elite or OEC 3D Operator Manuals: , this is an indication of a depleted coin cell battery. If this error is displayed, please contact GE Authorized Service. 5. Complete and return the attached response form promptly upon receipt and return to fieldactionssurgery@ge.com. 6. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Quantity

3 units

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.

Lot, serial or model codes

All OEC 3D Systems

510(k) numbers

["K203346"]

PMA numbers

not on file

Product code

OXO

Firm FEI

1720753

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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