FDA-Device2023-05-31Class II
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
PHILIPS HEADQUARTERS CAMBRIDGE
Hazard
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Sold states
AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam
Affected count
5 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1625-2023Don't want to check this manually?
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