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GE OEC Medical Systems, Inc recalls GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protectio
Recalled August 29, 2012 · FDA recall Z-2241-2012 · GE OEC Medical Systems
Hazard
GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. · FDA Class II
Units
845 units
Sold at
Worldwide and Nationwide (USA) distribution.
Description
GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation.
Product
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →