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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
All OEC 3D Systems
Products Sold
All OEC 3D Systems
GE OEC Medical Systems, Inc is recalling OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to pro due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026