FDA-Device2021-03-24Class II
Incisive CT Computed Tomography X-ray System Model: 728143
Philips North America Llc
Hazard
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
Sold states
US Virgin Island Foreign: Australia Bolivia China Germany Hungary Indonesia Italy Japan Korea Korea, Republic of Latvia Palestine Philippines Romania Russian Federation Senegal Thailand Uzbekistan
Affected count
105 units (1 US and 104 OUS)
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Incisive CT Computed Tomography X-ray System Model: 728143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1265-2021Don't want to check this manually?
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