Device product
Philips Healthcare Ingenuity CT 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.
Z-0017-2018
Product summary
- Event
- Event 78144
- Status
- Terminated
- Classification
- Class II
- Quantity
- US - 606
- Official record key
device-enforcement:Z-0017-2018
Official wording
Reason: 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.
Code information: Software version 4.16
Distribution pattern: USA (nationwide) Distribution
Derived failure modes
-
Unknown
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.