GE OEC Medical Systems, Inc
FDA Regulatory Profile
GE OEC Medical Systems, Inc appears in FDA public data with 48 recalls — including 6 Class I (most serious) —, 18 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0705-2025, Class II) was initiated on November 21, 2024. Its most recent 510(k) clearance was granted on March 28, 2024.
Summary
- Total Recalls
- 48 (6 Class I)
- 510(k) Clearances
- 18
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0705-2025 | Class II | OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluo | November 21, 2024 |
| Z-0706-2025 | Class II | OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designe | November 21, 2024 |
| Z-0704-2025 | Class II | OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is | November 21, 2024 |
| Z-0703-2025 | Class II | OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluorosco | November 21, 2024 |
| Z-2276-2023 | Class II | OEC 9800 Systems with 9-inch Image Intensifier | May 15, 2023 |
| Z-2277-2023 | Class II | OEC 9900 Systems with 9-inch Image Intensifier | May 15, 2023 |
| Z-2278-2023 | Class II | OEC Elite Systems with 9-inch Image Intensifier | May 15, 2023 |
| Z-2279-2023 | Class II | Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9 | May 15, 2023 |
| Z-2275-2023 | Class II | OEC Flexiview 8800 Systems with 9-inch Image Intensifier | May 15, 2023 |
| Z-2160-2021 | Class II | OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to pro | June 10, 2021 |
| Z-2161-2021 | Class II | OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of | June 10, 2021 |
| Z-1469-2017 | Class II | OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems | February 21, 2017 |
| Z-1059-2017 | Class II | OEC 9800. MDL Numbers: D222250, D141598 | December 27, 2016 |
| Z-1060-2017 | Class II | OEC 9900 Elite. MDL Numbers: D148942, D155043 | December 27, 2016 |
| Z-0975-2017 | Class II | The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film image | December 19, 2016 |
| Z-0974-2017 | Class II | OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to pr | December 19, 2016 |
| Z-0973-2017 | Class II | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-f | December 19, 2016 |
| Z-0071-2017 | Class II | OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo | September 23, 2016 |
| Z-2629-2016 | Class II | OEC 9800, fluoroscopic x-ray system | July 22, 2016 |
| Z-2628-2016 | Class II | OEC UroView 2800, fluoroscopic x-ray system | July 22, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233669 | OEC 3D | March 28, 2024 |
| K203346 | OEC 3D | March 5, 2021 |
| K192819 | OEC Elite | November 8, 2019 |
| K172550 | OEC Elite | November 16, 2017 |
| K171565 | OEC Elite | August 10, 2017 |
| K132027 | OEC 9800 PLUS | May 1, 2014 |
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS | October 4, 2011 |
| K073543 | OEC 9900 ELITE | May 2, 2008 |
| K061953 | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS | August 15, 2006 |
| K052039 | GE OEC ALTITUDE | August 11, 2005 |
| K051490 | GE OEC EVERVIEW 7500 | July 7, 2005 |
| K043076 | GE OEC FLUOROSTAR | December 22, 2004 |
| K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION | August 26, 2004 |
| K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM | August 18, 2004 |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | March 20, 2003 |
| K022069 | OEC FLUOROTRAK 9800 PLUS | September 17, 2002 |
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | April 17, 2002 |
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM | March 12, 2001 |