PlainRecalls
FDA Devices Moderate Class II Terminated

Philips Healthcare Brilliance iCT 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.

Reported: October 25, 2017 Initiated: January 18, 2017 #Z-0019-2018

Product Description

Philips Healthcare Brilliance iCT 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.

Details

Units Affected
US- 606
Distribution
USA (nationwide) Distribution
Location
Andover, MA

Frequently Asked Questions

What product was recalled?
Philips Healthcare Brilliance iCT 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.. Recalled by Philips Electronics North America Corporation. Units affected: US- 606.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0019-2018.