Reported Aug 1, 2012 · Terminated
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified…
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 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.
- Lot codes and dates
3,108 of 3,108 codes
8S-16638S-288789-311989-00988S-0152-C89-054082-125282-151989-232689-120489-327289-32738S-025882-067882-18848S-232182-204282-32108S-05338S-107789-091082-013982-387189-175789-329889-30268S-22998S-285789-204389-253389-246382-0356-RC8S-212089-18968S-7152-MH8S-7190-MH8S-32468S-028989-16268S-06258S-13018S-192089-10258S-18388S-13678S-162789-11128S-0076-RC8S-05088S-19468S-30738S-31058S-2324-C8S-00738S-01808S-223782-012682-304082-37108S-2647
- Amount recalled
- 8214 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 vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
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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