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U.S. Department of Health and Human Services

Class 2 Device Recall ProxiDiagnost N90

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  Class 2 Device Recall ProxiDiagnost N90 see related information
Date Initiated by Firm November 20, 2019
Create Date September 30, 2020
Recall Status1 Terminated 3 on April 04, 2024
Recall Number Z-3023-2020
Recall Event ID 86416
510(K)Number K173433  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ProxiDiagnost N90
Code Information All ProxiDiagnost N90 systems are affected.
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Dusty Leppert
978-659-3000
Manufacturer Reason
for Recall		 Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips sent an Urgent Field Safety Notice dated August 5, 2020 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. A Philips Field Service Engineers will schedule an appointment with customers to install the software update.
Quantity in Commerce 71
Distribution United States
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems DMC GmbH
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