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GE Medical Systems, LLC recalls GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applica
Recalled May 11, 2016 · FDA recall Z-1589-2016 · GE Medical Systems
Hazard
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. · FDA Class II
Units
26 (US = 4;OUS = 22)
Sold at
Worldwide Distribution - US including FL, GA, NC, and TX and Internationally to AUSTRALIA, CANADA, CHINA, FRANCE, GERMANY, ITALY, JAPAN, REPUBLIC OF KOREA, NORWAY, PERU, SWEDEN UNITED ARAB EMIRATES, UNITED KINGDOM.
Description
An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artifact. There is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail.
Product
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →