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Philips Electronics North America Corporation recalls CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F sys
Recalled January 17, 2018 · FDA recall Z-0330-2018 · Philips Electronics North America
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. · FDA Class II
Units
10
Sold at
Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Description
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.
Product
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
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →