FDA-Device2024-05-29Class II
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Philips North America Llc
Hazard
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
Sold states
Worldwide - US Nationwide distribution.
Affected count
18 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1871-2024Don't want to check this manually?
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