Z-2160-2021Class II

OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile -

Name: Z-2160-2021 OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile -
Creator: GE OEC Medical Systems, Inc
Published: 2021-06-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2021-06-10 / Terminated

FDA source

GE OEC Medical Systems, Inc began a recall of OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and... on 2021-06-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2160-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-10
Posted: 2021-07-29
Terminated: 2024-05-09
Recalling firm: GE Healthcare
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
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: All OEC 3D Systems

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2160-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2160-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-29
Z-2161-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-29

Product code OXO

K203346Class IIOec 3DGe Oec Medical Systems, Inc. / cleared 2021-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)