FDA-Device2023-08-09Class II
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Philips North America
Hazard
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Sold states
Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
Affected count
53 units OUS
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2260-2023Don't want to check this manually?
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