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

Recall Insight

This FDA Devices action (record #Z-1142-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on July 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Medical Systems (Cleveland) Inc is listed as the recalling firm, operating out of Cleveland, OH. Federal records indicate 23 units are affected.

The documented reason for this recall is: 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 col… Distribution data in the federal record shows the product reached: Distributed only to China and UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.