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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 R90 see related information
Date Initiated by Firm September 22, 2021
Create Date November 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-0241-2022
Recall Event ID 89023
510(K)Number K203087  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product CombiDiagnost R90 is multi-functional general R/F systems.
Code Information CombiDiagnost R90
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Dusty Leppert
978-228-0190
Manufacturer Reason
for Recall		 The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to DIFCO@philips.com. For questions contact Customer Care Solutions Center 1-800-722-9377.
Quantity in Commerce 281 in total
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = Philips Medical Systems DMC GmbH
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