FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
- Recall number
- Z-1462-2014
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
- Status
- Terminated
- Initiated
- 2014-03-31
- Posted
- 2014-04-16
- Terminated
- 2015-10-26
- Reason
- GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.
- Root cause
- Device Design
- Action
- GE Healthcare sent an Urgent Medical Device Correction letter dated March 31, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Use caution when positioning or extending the workstation articulating arm. In addition, refrain from positioning staff or patients directly underneath or in front of a workstation monitor. Your local GE Healthcare Field Engineer will contact you to coordinate the replacement of the screws, and ensure that your system is operating safely and meets all specifications. These activities will be performed at no cost to you. Should you have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately. UPDATE: On June 20, 2014. GE Healthcare Surgery began distributing an Urgent Medical Device Correction Letter to customers with affected units. The letter makes clear that this field correction applies to all user sites with the listed products, regardless of whether service work was performed on the monitor extension arm since 3/31/2014.
- Quantity
- 453 units
- Distribution
- Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
- Lot, serial or model codes
- Model Numbers - OEC 9900 Elite
- 510(k) numbers
- ["K061953","K073543","K082781"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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