Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-1143-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Brilliance 64, 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories

Product Classification:

Class II

Date Initiated: July 3, 2018

Date Posted: April 24, 2019

Recall Number: Z-1143-2019

Event ID: 80640

Reason for Recall:

Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.

Status: Terminated

Product Quantity: 14

Code Information:

10011 95620 10436 95486 95391 95838 95807 95621 10521 10255 10006 10715 10275 10616

Distribution Pattern:

Distributed only to China and UK.

Voluntary or Mandated:

Voluntary: Firm initiated