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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R2.1

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  Class 2 Device Recall Azurion R2.1 see related information
Date Initiated by Firm May 26, 2021
Create Date March 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-0734-2022
Recall Event ID 89742
510(K)Number K200917  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Azurion systems with software release R2.0.x
Code Information Model(s) Azurion R2.1
Recalling Firm/
Manufacturer		 Philips Healthcare
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact DUSTY LEPPERT, CHP
978-228-0190
Manufacturer Reason
for Recall		 In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Philips notified customers of the issue via an Electronic Product Radiation Defect notification letter dated February 8, 2022. Philips Field Service Engineers will schedule an appointment with customers to install the software update. Philips will correct the affected systems at no cost to customers with a software upgrade. For information, contact your local Philips representative: 1-800-722-9377.
Quantity in Commerce 69 systems
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 = OWB and Original Applicant = Philips Medical Systems Nederland BV
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