Reported Aug 1, 2012 · Terminated
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional…
GE OEC Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE OEC Medical Systems, Inc · 384 Wright Brothers Dr · Salt Lake City, UT · 84116-2862
Is this the product you have?
- 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.
- Lot codes and dates
1,947 of 1,947 codes
86-183486-117586-023886-058586-123086-199286-018486-103386-148086-136986-057986-167886-105986-063986-0389 & 86-039086-077586-0850 & 86-170386-0151 & 86-131186-188386-0048 & 86-201586-091586-1626 & 86-163186-211886-094986-093786-0071 & 86-101586-035286-052786-014086-169786-069786-116286-142486-079586-026086-007786-200286-081186-214886-158286-163386-045486-018586-1119 & 86-188586-066886-102686-052986-175486-090186-022886-155586-121286-109586-099786-147586-213786-082986-173786-125986-0013
- Amount recalled
- 1,933 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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