Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R3.0

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Azurion R3.0see related information
Date Initiated by FirmOctober 27, 2025
Date PostedDecember 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0597-2026
Recall Event ID 98052
510(K)NumberK200917 
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
ProductAzurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Code Information Model Number 722234 Commercial Name: Azurion 7 M20 How to identify: Philips Reference C&R 2025-IGT-BST-016
FEI Number 3006648320
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information Contact
978-482-2309
Manufacturer Reason
for Recall		Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPhilips will send a customer notification to the users of the affected systems to alert them of the issue and provide the actions that should be taken to prevent risks to patients. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the SSD spacer to resolve the issue.
Quantity in Commerce110
DistributionU.S.
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 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) Database510(K)s with Product Code = JAA
-
-