BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

Recall Insight

This FDA Devices action (record #Z-0931-2024) was formally reported on February 14, 2024, with the manufacturer initiating the action on December 15, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips North America is listed as the recalling firm, operating out of Cambridge, MA. Federal records indicate 106 US; 241 OUS units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as… Distribution data in the federal record shows the product reached: Domestic distribution nationwide. International distribution worldwide.. 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 2 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.