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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R2.0

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 Class 2 Device Recall Azurion R2.0see related information
Date Initiated by FirmMarch 21, 2023
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1647-2023
Recall Event ID 92165
510(K)NumberK181830 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductPhilips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion 7M12: 722078, 722223; (8) Azurion 7M20 : 722079, 722224
Code Information UDI-DI: System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21); (2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21); (3) Azurion SM12: 722227 (01)00884838099227(21); (4) Azurion SM20: 722228 (01)00884838099234(21); (5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21); (6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21); (7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21); (8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
FDA Determined
Cause 2		Under Investigation by firm
ActionPhilips issued Urgent Medical Device Letter to US consignees via e-mail on March 21, 2023 and certified email on March 29, 2023. Letters outside of the U.S.A. will be distributed through the local Philips Organizations. Letter states reason for recall, health risk and action to take: Keep this Medical Device Correction with the documentation of the system until Philips corrects your system. Circulate this notice to all users of the system so that they are aware of the issue. Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Medical Device Correction. US: Please return this signed form via email to: IGT_Recalls@philips.com or alternatively via regular mail to Philips at 222 Jacobs Street, Cambridge, MA 02141 for the attention of Mr. Roland Telson / 3rd Floor Philips is working on a software release that will correct this issue (reference FCO72200528). In the interim, until this software is available and installed in your affected system(s), Philips will be removing the Log Trace Files from the affected systems to free up disk capacity (reference FCO72200529). Philips will be prioritizing these activities based on the time the affected software release has been installed in the Philips Azurion system. You will be contacted by your local Philips representative to schedule these activities. If you need any further information or support concerning this issue, contact your local Philips representative.
Quantity in CommerceUSA: 1063 R.O.W. 2136
DistributionNationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador Egypt Estonia Finland France French Polynesia Germany Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Lithuania Macao Macedonia Malaysia Mexico Morocco Myanmar Nepal Netherlands New Zealand Nicaragua Nigeria Norway Oman Pakistan Palestine Palestine, State of Panama Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan Ukraine United Kingdom Utd.Arab.Emir. Uzbekistan Vietnam Yemen
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 = OWB
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