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Philips Electronics North America Corporation recalls Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are inte
Recalled October 25, 2017 · FDA recall Z-0015-2018 · Philips Electronics North America
Hazard
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient. · FDA Class II
Units
US - 606
Sold at
USA (nationwide) Distribution
Description
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
Product
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →