The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic
FDA device recall Z-1462-2014 · posted 2014-04-16 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 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
- Date initiated
- 2014-03-31
- Date posted
- 2014-04-16
- Date terminated
- 2015-10-26
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9900 ELITE (K082781) | Ge Healthcare Surgery | 2009-05-01 |
| OEC 9900 ELITE (K073543) | Ge Oec Medical Systems | 2008-05-02 |
| 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS (K061953) | Ge Oec Medical Systems | 2006-08-15 |