Recall Z-2038-2012— GE OEC Medical Systems, Inc
Class I · Terminated
Class I FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2008-02-22, terminated 2013-02-19. It names 3 FDA 510(k) clearances: K024012, K022069, K021049. Product: OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.. Reason: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure..
- Recalling firm
- GE OEC Medical Systems, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2008-02-22
- Terminated
- 2013-02-19
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K024012 — OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
- K022069 — OEC FLUOROTRAK 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Reason for recall
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.