Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-1142-2019)

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 16 Air, 728246 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-1142-2019

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: 23

Code Information:

6143 5701 50069 6232 6563 50007 5928 3466 6301 6328 50048 6145 5560 6324 5908 6520 5924 5496 6507 5944 6351 6149 6562

Distribution Pattern:

Distributed only to China and UK.

Voluntary or Mandated:

Voluntary: Firm initiated