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Health Canada Medical devices

BrightView XCT Imaging System and Gamma Camera System

Issued January 5, 2024
Issue
Philips has become aware of a potential safety issue affecting BrightView systems where the detector may unexpectedly fall due to a component failure. A detector support component may fail due to unexpected wear: Scenario 1: If the detector is below the center of the gantry bore and the detector support component fails, the detector may descend downward unexpectedly and potentially contact the patient. Scenario 2: If the detector is above the center of the gantry bore and the detector support component fails, the detector will not be able to move to complete the imaging. Philips has received a complaint associated with this issue; however, there are no reports of injury or serious harm. Recall start date: December 20, 2023
Hazard description
Performance
Product
Product name
BrightView XCT Imaging System and Gamma Camera System
Reference
ID
RA-74865