FDA recall Z-0018-2018

Product

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.

Reason for recall

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.

Distribution

USA (nationwide) Distribution

Key facts

Status

Terminated

Initiation date

2017-01-18

Report date

2017-10-25

Termination date

2020-02-26

Voluntary/Mandated

FDA Mandated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0018-2018