Device 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
Z-0330-2018
Product summary
- Event
- Event 78880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-0330-2018
Official wording
Reason: 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.
Code information: All CombiDiagnost R90 UDI 709030
Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Derived failure modes
-
Unknown
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.