Reported Aug 1, 2012 · Terminated
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to…
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 8800 Flexview892.1650 Image-intensified
- fluoroscopic x-ray system Product UsageThe 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
- Lot codes and dates
1,137 of 1,137 codes
2791PU22792PU02793PU82795PU32797PU92799PU52800PU12801PU92802PU72803PU52805PU02806PU82807PU72808PU42831PU62832PU42834PU02835PU72895PU12897PU72899PU32900PU92902PU52903PU32904PU12905PU82906PU6 & 4365PU32907PU43096PU53097PU33098PU13099PU9 & 3100PU53103PU93104PU73105PU43107PU03110PU43111PU23113PU8 & 3119PU53118PU73120PU33121PU13217PU7 & 5204PU33218PU53224PU34380PU2 & 4387PU73226PU83228PU43232PU63233PU43363PU93364PU7 & 4386PU93365PU43367PU03368PU83369PU63370PU43371PU23377PU93378PU7
- Amount recalled
- 1257 units (472 domestic systems)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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 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
Using this product could cause serious injury, illness or death — stop using it now.
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