Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.

Recall Insight

This FDA Devices action (record #Z-0400-2016) was formally reported on December 16, 2015, with the manufacturer initiating the action on April 25, 2006. 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 54 units units are affected.

The documented reason for this recall is: Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on t… Distribution data in the federal record shows the product reached: Worldwide distribution, including US states of CA and NV.. 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 11 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.