FDAFDA · Food and drugs·Recall number Z-0019-2018
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.
Published October 25, 2017 · Recall initiated: January 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- USA (nationwide) Distribution
- Lot
- Software version 4.16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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