Class II

Medical Device Recall: Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

Philips North America Llc · April 15, 2024

Reason for Recall

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

18 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1871-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.