Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2018 - (Recall #: Z-1396-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories

Product Classification:

Class II

Date Initiated: February 21, 2018

Date Posted: April 25, 2018

Recall Number: Z-1396-2018

Event ID: 79759

Reason for Recall:

Surview scan with tube current lower than 30 mA is unable to be initialized.

Status: Terminated

Product Quantity: 291

Code Information:

Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated