FDA-Device2018-01-17Class II
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
Philips Electronics North America Corporation
Hazard
The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance.
Sold states
Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Affected count
10
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0330-2018Don't want to check this manually?
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