Recall Z-2040-2012— GE OEC Medical Systems, Inc

Name: FDA recall Z-2040-2012
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: K992506. Product: OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.. 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 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo.

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

K992506 — MINI 6800 DIGITAL MOBILE C-ARMGe Dec Medical Systems·cleared 1999-08-19

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 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo

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