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U.S. Department of Health and Human Services

Class 2 Device Recall CombiDiagnost R90

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 Class 2 Device Recall CombiDiagnost R90see related information
Date Initiated by FirmOctober 19, 2017
Create DateJanuary 10, 2018
Recall Status1 Terminated 3 on September 20, 2018
Recall NumberZ-0330-2018
Recall Event ID 78880
510(K)NumberK163210 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductCombiDiagnost 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
Code Information All CombiDiagnost R90 UDI 709030
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactMichael Mizachi
978-659-3000
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionPhilips Medical System sent an Customer Notification letter dated October 19, 2017, and plans to have a Philips Field Service Engineer go to site to perform the field change order (FCO70900041) including: 1. Check for the presence of the PE cable and, if missing, install it. 2 .Perform a modified screw fixation. They expect to complete action by May 2018. For further questions, please call (978) 659-3000.
Quantity in Commerce10
DistributionWorldwide Distribution - US Distribution and to the countries of : France, Germany, Luxembourg and New Zealand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAA
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