Recall Z-0330-2018— Philips Electronics North America Corporation
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2017-10-19, terminated 2018-09-20. It names one FDA 510(k) clearance: K163210. 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. 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..
- Recalling firm
- Philips Electronics North America Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-19
- Terminated
- 2018-09-20
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.