Recall Z-2065-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2065-2012
Creator: U.S. Food and Drug Administration
Published: 2006-11-20

Class I · Terminated

Class I FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2006-11-20, terminated 2013-05-13. It names one FDA 510(k) clearance: K003837. Product: OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians 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 OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod.

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class I
Status: Terminated
Initiated: 2006-11-20
Terminated: 2013-05-13
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K003837 — FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems·cleared 2001-03-12

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 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians 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 OEC 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod

Data sourced from openFDA. This site is unofficial and independent of the FDA.