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.
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- March 31, 2014
- Posted
- April 16, 2014
- Terminated
- October 26, 2015
- Recall Number
- Z-1462-2014
- Quantity
- 453 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
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.
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 / Code Info
Model Numbers - OEC 9900 Elite
Root Cause
Device Design
Action Taken
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.