Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2017 - (Recall #: Z-1004-2017)

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:

Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories

Product Classification:

Class II

Date Initiated: November 25, 2016

Date Posted: January 18, 2017

Recall Number: Z-1004-2017

Event ID: 76021

Reason for Recall:

Failure to correctly document the installation of four M12 Bolts into the system rotor.

Status: Terminated

Product Quantity: 1

Code Information:

Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26

Distribution Pattern:

The one system was distributed in Canada. There were no government or US distribution.

Voluntary or Mandated:

Voluntary: Firm initiated