FDA-Device2017-10-25Class II
Philips Healthcare Ingenuity Core128 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.
Philips Electronics North America Corporation
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.
Sold states
USA (nationwide) Distribution
Affected count
US- 606
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips Healthcare Ingenuity Core128 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2018Don't want to check this manually?
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