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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 3D

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  Class 2 Device Recall OEC 3D see related information
Date Initiated by Firm June 10, 2021
Create Date July 29, 2021
Recall Status1 Completed
Recall Number Z-2160-2021
Recall Event ID 88202
510(K)Number K203346  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
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
Code Information All OEC 3D Systems
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact GE Healthcare Surgery
1800-536-4890
Manufacturer 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 Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = GE OEC Medical Systems, Inc.
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