Philips Electronics North America Corporation: Medical Device Recall in 2017 - (Recall #: Z-0015-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Philips Healthcare Brilliance 64 System, 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.

Product Classification:

Class II

Date Initiated: January 18, 2017

Date Posted: October 25, 2017

Recall Number: Z-0015-2018

Event ID: 78144

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.

Status: Terminated

Product Quantity: US - 606

Code Information:

Software version 4.16

Distribution Pattern:

USA (nationwide) Distribution

Voluntary or Mandated:

FDA Mandated